[Senate Hearing 114-804]
[From the U.S. Government Publishing Office]
S. Hrg. 114-804
EXPLORING CURRENT PRACTICES IN COSMETIC DEVELOPMENT AND SAFETY
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING EXPLORING CURRENT PRACTICES IN COSMETIC DEVELOPMENT AND
SAFETY, INCLUDING S. 1014, TO AMEND THE FEDERAL FOOD, DRUG, AND
COSMETIC ACT TO ENSURE THE SAFETY OF COSMETICS
__________
SEPTEMBER 22, 2016
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
(ii)
C O N T E N T S
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STATEMENTS
THURSDAY, SEPTEMBER 22, 2016
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Murray, Hon. Patty, a U.S. Senator from the State of Washington.. 3
Bennet, Hon. Michael F., a U.S. Senator from the State of
Colorado....................................................... 4
Franken, Hon. Al, a U.S. Senator from the State of Minnesota..... 29
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana... 31
Witnesses--Panel I
Feinstein, Hon. Dianne, a U.S. Senator from the State of
California..................................................... 5
Collins, Hon. Susan, a U.S. Senator from the State of Maine...... 8
Witnesses--Panel II
Jonas, Beth Lange, Ph.D., Chief Scientist, Personal Care Products
Council, Washington, DC........................................ 10
Prepared statement........................................... 11
Bergfeld, Wilma, M.D., Senior Dermatologist and Emeritus Director
of Dermatopathology, Director of Dermatopathology Fellowship,
and Professor of Dermatology and Pathology, Departments of
Dermatology and Pathology at Cleveland Clinic, and Chair of
Cosmetic Ingredient Review, Cleveland, OH...................... 14
Prepared statement........................................... 15
Faber, Scott, J.D., Senior Vice President of Government Affairs,
Environmental Working Group, Washington, DC.................... 16
Prepared Statement........................................... 17
Dandurand, Curran, CEO and Co-Founder, Jack Black LLC,
Carrollton, Texas.............................................. 24
Prepared statement........................................... 25
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Senator Baldwin, prepared statement.......................... 34
Anne-Marie Faiola, President of the Coalition of Handcrafted
Entrepreneurs, prepared statement.......................... 34
Their Hair Fell Out: Should the F.D.A. Have the Power to
Act?, article, New York Times.............................. 36
Response by the Department of Health & Human Services, Food
and Drug Administration, to questions of Senator Alexander. 41
Response by Beth Lange Jonas, Ph.D., to questions of:
Senator Alexander........................................ 48
Senator Murray........................................... 50
Senator Enzi............................................. 52
Senator Hatch............................................ 53
(iii)
Response by Wilma Bergfeld, M.D. to questions of:
Senator Alexander........................................ 53
Senator Murray........................................... 56
Senator Enzi............................................. 57
Senator Hatch............................................ 58
Senator Murphy........................................... 60
Senator Warren........................................... 60
Response by Scott Faber to questions of:
Senator Murray........................................... 68
Senator Enzi............................................. 70
Senator Hatch............................................ 71
Senator Baldwin.......................................... 71
Response by Curran Dandurand to questions of:
Senator Alexander........................................ 72
Senator Murray........................................... 73
Senator Enzi............................................. 74
Senator Hatch............................................ 75
Senator Baldwin.......................................... 75
EXPLORING CURRENT PRACTICES IN COSMETIC DEVELOPMENT AND SAFETY
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THURSDAY, SEPTEMBER 22, 2016
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m. in room
SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander
presiding.
Present: Senator Alexander, Murray, Collins, Cassidy,
Franken, and Bennet.
Opening Statement of Senator Alexander
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will please come to order. We are holding a
hearing today on the development and safety of cosmetics and
personal care products.
Senator Murray and I will each have an opening statement.
Senator Bennet has another appointment, and he has to leave
early, so he will speak briefly after Senator Murray.
Senator Feinstein is here today as she has taken a great
interest in cosmetics safety and has asked that I hold this
hearing today, and we are glad to do that.
She has introduced a bill in the Senate along with Senator
Collins. We welcome Senator Collins, who is a member of the
committee and a strong advocate for the legislation.
They will each have 5 minutes at the beginning of the
hearing to give a statement. After that, we will introduce our
second panel of witnesses. After our witness testimony, we will
have 5 minutes of questions.
Today's hearing is an opportunity for the committee to
learn about how cosmetics and personal care products are
developed, what is being done to make sure they are safe, and
how we can improve to better ensure the safety of the products
that Americans spend $60 billion on each year.
Most hearings should really be called ``talkings'' because
Senators do a lot of talking, but today I'm planning on this
being a true hearing. I am eager to learn and will spend most
of my time listening to what our witnesses have to say.
I am grateful to Senator Feinstein and Senator Collins for
asking us to take a look at the issue.
This is the first time since 1974 that our committee has
held a hearing on cosmetics and personal care products. It is
pretty remarkable given how frequently most Americans come into
contact with these products.
Cosmetics aren't just lipsticks and fingernail polish. They
include a wide range of personal care products.
When a father brushes his toddler's teeth at night or draws
him a bubble bath, he is using what the law defines as
cosmetics. In the morning, when that father uses shaving cream
or deodorant, he is using cosmetics.
There are an estimated 8 billion personal care products
sold in our country each year. In a 1-year period from 2014 to
2015, the average U.S. household spent over $650 on personal
care products and services.
My hope today is to better understand how those products
are developed, how safe they are, how they are reviewed, how
they go to market, and how individual ingredients are reviewed
to make sure they are safe.
We will also hear about possible public health and safety
challenges.
Congress, through the Federal Food, Drug, and Cosmetic Act,
along with the Fair Packaging and Labeling Act, gave the Food
and Drug Administration the authority to regulate cosmetics.
Cosmetics Congress defined as products intended for
``cleansing, beautifying, promoting attractiveness, or altering
the appearance.''
Congress gave FDA a variety of powers to make sure
cosmetics are, one, labeled correctly; two, safe for use; and
don't contain ingredients that would cause harm or are
contaminated.
To do that job, FDA has a number of tools, including the
ability to inspect cosmetic manufacturers, the ability to
receive and review reports on adverse customer reaction, or the
power to remove any adulterated or misbranded cosmetics from
the market.
Much of what we think of as cosmetics are also subject to
other regulations.
For example, if a cosmetic product is intended to help in
the diagnosis of a disease, then it is also regulated as a
drug. Toothpaste, for example, is a cosmetic, but fluoride
toothpaste is regulated as a drug. Moisturizer is a cosmetic,
but moisturizer with sunscreen is regulated as a drug.
What happens if a cosmetic causes harm?
FDA maintains an adverse event reporting system known as
CAERS, which tracks adverse events associated with cosmetics as
well as food and dietary supplements.
There is a story in the news this year about a line of hair
products called WEN that have reportedly caused rashes and hair
loss. FDA received 127 adverse event reports related to WEN
between February 2011 and July 7, 2016.
That is a lot of reports, given that FDA typically receives
reports for between 300 and 400 adverse events each year.
The cosmetics industry has its own review process. It has
had that since 1976. It is called CIR. It is an independent
panel created by the Personal Care Products Council.
This panel includes physicians and scientists from
universities, hospitals, and laboratories around the country
who review and assess the safety of ingredients used in
cosmetics.
We will hear from them today.
I am concerned that FDA already has a full plate of
responsibilities in protecting the public health. I want to see
if we want to strengthen and improve current practices,
including those of CIR or FDA. If so, how can Congress help
ensure FDA has the tools it needs?
Before I introduce our four outside witnesses, I will
introduce Senator Feinstein and Senator Collins. They will talk
about their bill. But we will do that a little later.
First, we will hear from Senator Murray and then from
Senator Bennet when he comes.
Senator Murray.
Opening Statement of Senator Murray
Senator Murray. Thank you very much, Chairman Alexander. I
am really pleased that we are holding this hearing to talk
about products that millions of consumers and families use each
day.
Congress has spent a great deal of time modernizing nearly
every aspect of the Food, Drug and Cosmetic Act. I am proud to
have worked with my colleagues on many of these vital changes,
from drug approval and device review to oversight of compound
medications and food safety. These have been important advances
for consumers and families, but the cosmetics portion of the
law has barely been touched since it passed in 1938.
Since passage of the Act in 1938, the cosmetics industry
has grown exponentially and is now a $60 billion industry
comprised of businesses of all sizes, from at-home startups to
large multinational corporations. But in spite of that
explosive growth putting millions of products on the market,
the FDA's authority has not changed, and it has minimal ability
to protect consumers and families.
FDA has no authority to review or confirm the safety of the
ingredients in fragrances used in cosmetics before they enter
the market. It has no authority to remove products from the
market even if a product has been shown to cause harm.
The cosmetics industry performs toxicity and allergy
testing, but with such little attention from the regulator,
consumers and families cannot be sure that the ingredients are
safe for their long-term health.
This lack of legal authority was highlighted in July when
the FDA issued a safety alert to warn consumers and families
about adverse events related to WEN hair care products. The
agency, as the chairman just mentioned, began examining the WEN
products after it received over 100 adverse event reports of
hair loss and severe damage.
Shockingly, the FDA's investigation uncovered over 21,000
more consumer complaints reported to the company.
Unlike the law governing drugs and medical devices, the
company had no legal obligation to share these complaints with
the FDA. Even now after the FDA is aware of these complaints,
the agency doesn't have the authority to remove the products
from the market.
As of this morning, even after the FDA safety alert and
press coverage of hair-loss issues, the WEN website makes no
clear mention of the potential side effects of their products
to allow consumers and families to make an informed choice.
This is an issue that affects everyone. Millions of
consumers and families purchase cosmetics and personal care
products believing the FDA is reviewing and monitoring the
ingredients. This lack of oversight is especially concerning
for women and children who are more sensitive to exposure to
chemicals.
I am glad that, in the absence of stricter Federal laws,
the individual States like my home State of Washington have
taken steps to restrict or reduce the use of certain
ingredients.
I am very pleased that our colleagues Senator Feinstein and
Senator Collins are here to talk about their bipartisan work
that they have done over the past several years to highlight
and address some of the shortfalls in our system. I really
commend their work to bring together so many stakeholders from
the business and consumer community to develop the Personal
Care Product Safety Act.
While the details of this bill are not the main focus of
this hearing today, the principle that guided its development,
that Americans need more assurance the products they use every
day are safe, certainly is.
I look forward to hearing from our second panel of expert
witnesses about the work being done by the industry to develop
cosmetic products and hearing more about how sensible
regulation can raise the bar for our consumers and families.
Thank you very much, Mr. Chairman.
The Chairman. Thanks, Senator Murray.
Senator Bennet has another appointment, so if he would like
to make a statement now, he is recognized.
Statement of Senator Bennet
Senator Bennet. Thank you, Mr. Chairman. I really
appreciate you fitting me in. I thank you and the Ranking
Member, Patty Murray, for holding this hearing today. Thank you
to our colleagues Senator Dianne Feinstein and Senator Susan
Collins for their tremendous leadership on this issue.
I think it is critical for the HELP Committee to explore
current practices in the personal care and cosmetics industry,
including safety concerns and regulatory oversight. All of us
here today would agree that consumers who buy personal care
products should not be afraid that the ingredients will
threaten their safety or cause serious adverse harm.
Eleven-year-old Eliana Lawrence from Denver bravely came to
my office to share her story about losing all of her hair after
using WEN shampoo. Many of you may have heard of WEN hair care
on late-night infomercials. With over 22,000 complaints about
its products, the company is still running infomercials today,
and the FDA has neither the resources nor the authority to act.
Eliana, along with her mother, Miriam, told our office
about how tough it was to lose her hair at 9 years of age for
no explainable reason. People can be cruel in these kinds of
situations, and she ultimately had to change schools.
Eliana and her mom came to Capitol Hill to advocate for
fairer laws so this never happens to another child, and we
promised to work to resolve this issue with the committee.
I want to thank her for her passion and others in Colorado
who have been advocating for transparency in safety in the
personal care products area.
Small businesses in my home State that make products like
handmade soap and other personal care items have also made it
clear to me that we need a solution that balances safety with
appropriate flexibility for small businesses.
Thank you, Mr. Chairman. I look forward to hearing from
Senator Feinstein and Senator Collins, and working with you and
the ranking member on finding consensus on this important
issue.
The Chairman. Thank you, Senator Bennet.
Now it is my pleasure to recognize Senator Feinstein of
California, followed by Senator Collins of Maine. Senator
Collins is, of course, a member of this committee.
They have introduced legislation, S. 1014, the Personal
Care Products Safety Act, to modernize the Food and Drug
Administration's regulation of cosmetics and personal care
products.
Senator Feinstein, welcome.
Statement of Senator Feinstein
Senator Feinstein. Thank you very much, Mr. Chairman. Thank
you so much for scheduling this hearing. It is much
appreciated.
I also want to thank my cosponsor. Thank you so much,
Susan, for working together with me on this.
I would also like to acknowledge a few who are in the
audience today, including representatives from Johnson &
Johnson, the maker of brands including Neutrogena, Aveeno, and
Johnson's baby products. I am grateful for them putting out
this flyer indicating their support for our bill. Also, Procter
& Gamble, maker of brands such as Pantene, Head and Shoulders,
Clairol, Secret, and Olay; and Revlon.
We also have representatives from science and consumer
groups, including the Endocrine Society, Good Housekeeping
Institute, and Environmental Working Group. A member there is
on the panel.
Mr. Chairman, the laws governing the safety of personal
care products, which every American uses every day, have not
been really updated since 1938.
Let me begin. Our skin is our largest organ, and many
ingredients contained in these products, whether it be lotion,
shampoo, or deodorant, are quickly absorbed by the skin.
Think about it for a moment. Nicotine patches to help
people stop smoking and pain patches deliver potent drugs
through the skin. The chemicals in personal care products are
also absorbed, even through our nails.
There is increasing evidence that certain ingredients in
personal care products are linked to a range of health
concerns, ranging from reproductive issues, such as fertility
problems and miscarriage, to cancer.
I would like to touch on just a couple of examples.
It was formaldehyde that brought me to this issue and
watching Brazilian blowouts being administered in cramped
quarters in beauty salons. Formaldehyde can cause shortness of
breath, headaches, and dizziness in the short term. In the long
term, it's been linked to cancer.
Also, gel nail polishes, they last longer, often contain a
number of concerning chemicals, including what has been called
the ``toxic trio.''
Manicurists who apply these polishes are at increased risk.
They work long hours, and they breathe fumes all day. In some
salons, there can be very poor ventilation. This can lead to
health issues like respiratory difficulties and even fertility
problems.
To remove this long-lasting polish, nails must be soaked in
acetone, another chemical considered to be potentially
hazardous by the Occupational Safety and Health Administration.
Because of outdated safety rules, the FDA has prohibited or
restricted only 11 substances, including mercury and
chloroform, from use in personal care products.
In contrast, the European Union has had an ingredient
review process for personal care products in place for decades.
The EU has banned more than 1,300 chemicals from personal care
products and restricted an additional 256. In addition,
additives and colors may only be used if they are pre-approved.
More than 8 years ago now, I started working on legislation
to update the safety rules for personal care products. About 3
years ago, we found there was increased concern in the industry
too, and a willingness among stakeholders to come together.
I spoke with a man by the name of Leonard Lauder, the
chairman of the Estee Lauder companies and a long-time friend.
I asked him, ``What do you think of this?'' He said, ``I think
it might be a very good idea.''
In the process of developing this legislation, we
consulted: companies, large and small; doctors; consumer
advocates; patient advocates; scientists; and the Food and Drug
Administration.
It took countless hours of calls and meetings from my
staff, but Senator Collins and I were able to put together then
the first bill introduced on this subject to have bipartisan
support, as well as support from a wide-ranging coalition of
companies and consumer and health organizations.
Let me name a few:
L'Oreal, which makes Garnier, Mabelline, Lancome,
Redken, Keihl's, Essie, and the Body Shop products
Unilever, with brands such as Dove, Suave, and
Vaseline
California Baby, a popular natural children's
brand
March of Dimes
Society for Women's Health Research
American Cancer Society
These are just some of the 17 companies, representing over
160 brands, and 24 organizations that have come together to
form exactly the type of broad coalition needed to get a bill
done.
Now let me say for a moment what the bill does. The
Personal Care Products Safety Act would give the FDA the
authority to review five ingredients in personal care products
each year to determine if they're safe. FDA may review
additional ingredients, if needed.
The bill actually lists the first five ingredients to be
reviewed, and they were chosen on the basis of extensive
consultation with companies, health advocates, and scientists.
There is agreement from all sides that these ingredients should
be independently reviewed.
After the first five ingredients, FDA would choose
chemicals to review based on feedback from scientists, health
advocates, and companies.
Lead acetate, which is used as a color additive in
hair dyes is one of the five.
Methylene glycol or formaldehyde, used in
Brazilian blowouts, is one of the five.
The next three to be reviewed are endocrine disruptors.
Overexposure to these chemicals is linked to a range of health
problems, including impacts on the immune system, healthy
pregnancies, fertility, and even some cancers. They are used as
preservatives in a wide range of products, including shampoo,
conditioner, lotion, bubble bath, and deodorant. They are:
Diazolidinyl urea
Propyl paraben
Quaternium-15
The ingredient review process would provide a uniform
safety standard for ingredients used by the industry to give
consumers the confidence that the products they and their
families use are safe.
One point I want to stress: Independent review of
ingredients isn't just something health and consumer
organizations want. It is also something we've learned
companies want.
With minimal regulation, companies are left to make their
own decisions about potentially harmful ingredients. Do they
use the ingredient or not? Do they use just a very small amount
of the ingredient? Having an independent arbiter answer these
questions is good for the industry.
The bill would also:
Require companies to report serious health
events--WEN as Senator Bennet mentioned might well be one of
them--brought to their attention to the FDA within 15 days.
Provide the FDA with mandatory recall authority.
Require manufacturer to register with the FDA and
provide ingredient information.
FDA would issue Good Manufacturing Practices to
ensure products are being produced safely.
Mr. Chairman, personal care product safety is an issue that
affects us all--male, female, and juvenile--and it needs to be
taken seriously. I hope that your committee will take the steps
to move this bill forward.
I want to thank you and the Senators here today for
listening to this testimony.
Thank you very much, Mr. Chairman.
The Chairman. Thank you, Senator Feinstein.
Senator Collins.
Statement of Senator Collins
Senator Collins. Thank you, Mr. Chairman.
Let me echo Senator Feinstein's thanks to you and the
ranking member for holding this hearing and inviting us to
testify on the important topic of the safety of personal care
products.
I also want to salute Senator Feinstein for her
longstanding interest and leadership on this issue.
As she noted, Americans use a variety of personal care
products daily, from shampoos and lotions to cosmetics and
deodorants. Consumers should be able to know whether the
products that they are applying to their own skin or the skin
of their children and their hair are safe.
While many companies have made a strong commitment to
safety on a voluntary basis, under the current law, the Food
and Drug Administration has surprisingly very little authority
to protect consumers. They even lack a mandatory recall
authority when a product is found to be harmful.
As has been mentioned numerous times, this summer, we were
all alarmed to learn the devastating account of a 9-year-old
girl who lost all of her hair after using a WEN hair product.
Here is what is interesting to me. It turns out that the
company had received more than 21,000 consumer reports of
harmful effects, while the FDA had received a mere 127 reports
at the time the agency announced in July that it would
investigate claims of hair loss, hair breakage, balding,
itching, and rashes. That number has since grown to more than
1,000 reports. Still, a huge difference between the reports
that company received versus FDA.
Yet that company, that personal care products company, is
not required to report to the FDA about adverse events. I
believe that is the key weakness in the current law.
Understandably, there is significant concern from
consumers, salon workers, manufacturers, and health
professionals that the current system is failing consumers. I
am particularly concerned about the impact on children and on
professionals like hair stylists who may be exposed to
potentially harmful ingredients in products they use every
workday.
To help address this issue, I have joined with Senator
Feinstein in introducing our bipartisan Personal Care Products
Safety Act, which would modernize our woefully outdated Federal
regulatory system.
As Senator Murray indicated, it is ironic that we have
addressed and modernized the FDA in so many other areas but not
in this one.
Our bill is the product of consultations with a wide range
of stakeholders, as Senator Feinstein has mentioned, and it
would give the FDA broader oversight by setting up a basic
regulatory structure, with registration of manufacturers and
products, with review of ingredients by the FDA, and by a
uniform national standard.
With the news that a bipartisan House companion bill has
been released, we are encouraged that this effort is gaining
more support and resonating with the American public.
While our bill is endorsed by a diverse and growing
coalition of groups, including companies and consumer and
health organizations, there are some small, artisan soap and
homemade cosmetic producers that have expressed concern. Given
that, I would like to clear up some misconceptions about our
bill and mention provisions that aim to help protect small
companies.
First, only soap products that make cosmetic claims would
be included in the new system.
Second, individuals or small companies selling less than
$100,000 in products annually would not be required to register
with the FDA. For companies selling between $100,000 and
$500,000 worth of products, there would be a simplified
registration process and no user fee. The user fee schedule,
similar to that which already exists for drug and device
companies, and which helps to avoid costs to taxpayers,
increases as the size of a company grows.
Finally, the FDA and the Small Business Administration
would help ensure that compliance is simple and easy to
understand.
Mr. Chairman, thank you so much for the opportunity to
testify today. By modernizing the oversight of personal care
products that are used so widely by the American public,
consumers will be better informed and protected.
Thank you.
The Chairman. Thank you, Senator Collins, and thank you,
Senator Feinstein.
We will now welcome our four witnesses to today's hearing.
As they move up, I will go ahead and introduce them.
First, we will hear from Dr. Beth Jonas who is chief
scientist at the Personal Care Products Council where she is
responsible for providing scientific direction and support to
the council within the personal care products industry.
Next, we will hear from Dr. Wilma Bergfeld. She serves in a
senior position within the Departments of Dermatopathology and
Dermatopathology at Cleveland Clinic. She is a former chair and
current consultant to the FDA Dermatology and Ophthalmology
Advisory Committee.
Next, we will hear from Scott Faber. He is senior vice
president of government affairs at the Environmental Working
Group. He holds a J.D. from Georgetown University Law, where he
is currently a professor.
Last, we will hear from Ms. Curran Dandurand. She is the
chief executive officer and co-founder of Jack Black, a leading
brand in the premium men's skin care market. Since founding the
company in her home in 2000, the privately held company has
grown exponentially, now employing 80 people and is sold in all
50 States and around the world.
Let me ask each of the witnesses to please summarize their
testimony in about 5 minutes, if you can. That will leave more
time for Senators to ask questions.
We will begin with Dr. Jonas.
Welcome.
STATEMENT OF BETH LANGE JONAS, Ph.D., CHIEF SCIENTIST, PERSONAL
CARE PRODUCTS COUNCIL, WASHINGTON, DC
Ms. Jonas. Thank you. First, let me thank Senators
Feinstein and Collins for their leadership on this very
important issue. We are pleased to be here today.
Chairman Alexander, Senator Murray, and distinguished
members of the committee, thank you for the opportunity to
appear before you on behalf of the Personal Care Products
Council.
My name is Beth Jonas, and I am the organization's chief
scientist, and I hold a Ph.D. in radiation biology from the
University of Iowa. I also am a member of the American Academy
of Dermatology.
I have more than 20 years' senior management experience
working for personal care products companies and have been
granted more than 20 U.S. and European patents.
I am here today to speak about the important role that
science plays in the cosmetics and personal care products
industry, and how the industry enhances the lives of American
families who trust and rely on these products every day.
The Personal Care Products Council represents 600 large-,
medium-, and small-sized companies that manufacture and
distribute many of the most trusted brands in beauty and
personal care. Our products are among the safest product
categories regulated by the FDA.
The FDA has clear authority to regulate the safety of these
products under the Food, Drug and Cosmetic Act, which requires
that every product and its individual ingredients be
substantiated for safety before they are put on the market, and
that the labeling of those products be truthful and not
misleading.
It is a company's clear responsibility to ensure that its
products comply with the law and that the current law provides
penalties for manufacturers that do not meet these standards.
Safety is the top priority for our industry. With careful
and thorough scientific research and development serving as the
foundation for everything that we do, our industry invests
nearly $3 billion in the U.S. each year in scientific research
and development.
The industry employs nearly 6,000 scientific and technical
professionals dedicated to ensuring product safety.
Companies also work with a number of scientific and medical
experts, such as toxicologists, microbiologists,
dermatologists, environmental scientists, and other experts to
evaluate the safety of their products before they reach the
consumer.
In addition to outside experts, companies use pre-clinical
and clinical safety testing as a means to substantiate the
safety of both ingredients and finished products. Once the
relevant safety data are assembled, a risk assessment must be
conducted to see if the data provide an inadequate margin of
safety given the particular exposure circumstances.
Companies conduct product safety evaluations using the same
science-based approaches embedded in research practices at FDA,
EPA, and other regulatory agencies around the world.
Cosmetic safety assessments are thorough, addressing
numerous health questions, including, but not limited to, the
potential for cancer, reproductive harm, and allergic
reactions. The foundation of a science-based safety assessment
is that any ingredient has a safe range and an unsafe range,
whether it is water, or a vitamin, or a newly discovered
compound. An ingredient's safe range is defined through many
studies before it can be used in a product. Safety is about
choosing ingredients that can be used well within their safe
range and avoiding ingredients that cannot.
A complete safety assessment also accounts for who uses the
products, how often they are used, and how they are used over a
lifetime.
The product development cycle can take up to 2 years to
complete, and sometimes longer.
Once a product is on the market, an active and structured
surveillance of the consumer experience during use can be used
to further support product safety.
A manufacturer should establish a post-market surveillance
process for the reporting, recording, and review of adverse
health events related to their products. A properly structured
surveillance process will also help identify consumer use
patterns, such as alternate uses, which may contribute to
adverse effects.
In addition to the work of each individual company, our
trade association supports independent programs to review
ingredient safety. The most significant example is the Cosmetic
Ingredient Review established with the involvement and support
of the FDA and the Consumer Federation of America.
We look forward to working with Congress and key
stakeholders, as we have for nearly a decade. We want to
modernize FDA's regulatory authority over our industry. We
support the creation of a national standard that maintains the
continued safety of products while providing the agency with
the resources it needs.
Despite this long safety record, a comprehensive national
program is needed to ensure uniform regulations of cosmetics
throughout the country and to prevent an unworkable patchwork
of differing State requirements.
We support mandatory registration with FDA of manufacturing
facilities and ingredient statements, authorizing FDA to issue
good manufacturing practices for cosmetics, reporting to FDA
serious adverse events, and creation of a program for FDA to
review the safety of cosmetic ingredients.
We believe a strong national standard will give businesses
the certainty they need to continue to innovate while providing
consumers with the products they trust and love.
In closing, we will continue to proactively work to ensure
that our products contribute to the well-being of American
consumers.
On behalf of the members of the Personal Care Products
Council, thank you for the opportunity to be here today, and we
look forward to working with Congress to move reform forward.
[The prepared statement of Ms. Jonas follows:]
Prepared Statement of Beth Lange Jonas, Ph.D.
summary
Cosmetics and personal care products are among the safest product
categories regulated by the Food & Drug Administration (FDA). FDA has
clear authority to regulate the safety of these products under the
Food, Drug & Cosmetic Act, which requires that every product and its
individual ingredients be substantiated for safety before they are put
on the market, and that the labeling of those products be truthful and
not misleading.
Consumer and product safety are top priorities for our industry,
with careful and thorough scientific research and development serving
as the foundation for everything that we do. Companies employ and work
with a number of scientific and medical experts--chemists,
toxicologists, microbiologists, dermatologists, epidemiologists,
environmental scientists and other technical experts--to evaluate and
ensure the safety of their products before they reach the consumer. The
product development cycle can take up to 2 years to complete, sometimes
longer.
We are a major source of high-paying manufacturing and management
jobs and are committed to a diverse workforce. Our companies employ
more women and people of color in management positions than the
national average. Women and people of color account for nearly 74
percent of all employment in the personal care products sector and 61.2
percent of management positions.
We have worked with Congress and key stakeholders for nearly a
decade--to modernize FDA's regulatory authority over our industry. We
support the creation of a comprehensive national program to assure
uniform regulation of cosmetics throughout the country. We also support
mandatory registration with FDA of manufacturing facilities and
ingredient statements; authorizing FDA to issue Good Manufacturing
Practices for cosmetics; reporting to FDA serious adverse events; and
creation of a program for FDA to review the safety of cosmetic
ingredients.
In summary, our work and that of our members is based on sound
scientific principles. Our industry puts consumer safety first, and we
will continue to proactively work to ensure the products we manufacture
contribute to the well-being of American consumers.
______
Chairman Alexander, Ranking Member Murray and distinguished members
of the committee, thank you for the opportunity to appear before you on
behalf of the Personal Care Products Council. My name is Beth Jonas. I
am the Chief Scientist for the Personal Care Products Council and I
hold a Ph.D. in Radiation Biology from the University of Iowa, College
of Medicine. I also am a member of the American Academy of Dermatology.
Prior to joining the Council, I was the Chief Scientific Officer at
Mary Kay Inc. I joined Mary Kay from Schering Plough Consumer Health
where I served as Senior Director of Worldwide Skin Care and
International over-the-counter medicines. I have held management
positions at Kimberly Clark and Unilever corporations and have been
granted more than 20 United States and European patents. I am here
today to speak about the important role that science plays in the
cosmetics and personal care products industry and how this industry
enhances the lives of millions of American families who trust and rely
on these products every day.
The Personal Care Products Council is one of the oldest and most
established trade associations in Washington. We represent
approximately 600 large, medium and small sized companies that
manufacture and distribute many of the most trusted and beloved brands
in beauty and personal care today.
Cosmetics and personal care products are among the safest product
categories regulated by the Food & Drug Administration (FDA). FDA has
clear authority to regulate the safety of these products under the
Food, Drug & Cosmetic Act, which requires that every product and its
individual ingredients be substantiated for safety before they are put
on the market, and that the labeling of those products be truthful and
not misleading. It is a company's clear responsibility to ensure that
its products comply with the law and the current law provides penalties
for manufacturers that do not meet these standards. Companies take
their responsibility for safety very seriously.
Consumer and product safety are top priorities for our industry,
with careful and thorough scientific research and development serving
as the foundation for everything that we do. The U.S. cosmetics
industry invests nearly $3 billion each year in scientific research and
development. As a result of this research, approximately 2,000 new
products are launched annually, and numerous scientific papers are
published on enhancing or developing new safety methods.
The industry employs nearly 6,000 scientific and technical
professionals dedicated to ensuring product and ingredient safety.
Companies also work with a number of scientific and medical experts--
chemists, toxicologists, microbiologists, dermatologists,
epidemiologists, environmental scientists and other technical experts--
to evaluate and ensure the safety of their products before they reach
the consumer. In addition to outside experts, companies use pre-
clinical and clinical safety testing as a means to substantiate the
safety of both ingredients and finished cosmetic products. Pre-clinical
testing may include in vitro alternative methods using cell and tissue
cultures following accepted regulatory guidelines when available. In
silico methods, such as the use of structure-activity relationships,
may add to the overall weight of the evidence for safety evaluation.
Clinical testing involves confirming safety testing with human
volunteers. Once the relevant safety data are assembled, a risk
assessment must be conducted to see if the data provide an adequate
margin of safety given the particular exposure circumstances.
Companies conduct product safety evaluations using the same
science-based approaches embedded in the research practices at FDA,
EPA, and other regulatory agencies around the world. Cosmetic safety
assessments are thorough and address numerous health questions,
including, but not limited to the potential for cancer, reproductive
harm, allergic reactions, and how an ingredient is cleared if it goes
through the body. The foundation of science-based safety assessments is
that any ingredient has a safe range and an unsafe range whether it is
water, or a vitamin, or a newly discovered compound. An ingredient's
safe range is defined through many, many studies before it can be used
in a product. Safety is about choosing ingredients that can be used
well within their safe range and within certain formulations, and
avoiding ingredients that cannot be used safely. A complete safety
assessment also accounts for who uses the products, how they are used
and how often, over a lifetime. Finally, companies' post market
surveillance of the consumer experience acts to affirm product safety.
The product development cycle can take up to 2 years to complete,
sometimes longer.
Once a product is on the market, an active and structured
surveillance of consumer experience during use can be used to further
support product safety. For most products, the marketplace represents a
much larger and diverse population than any of those used to evaluate a
product during pre-market activities. Therefore, unanticipated safety-
related concerns with a product may be revealed. A manufacturer should
establish a post-market surveillance process for the reporting,
recording and review of adverse health effects related to their
products. A properly structured surveillance process will also help
identify consumer use patterns, such as alternate uses or product
combinations, which may contribute to adverse effects.
In addition to the work of each individual company, our trade
association supports independent programs to review product and
ingredient safety. Perhaps the most significant example of this is the
Cosmetic Ingredient Review Expert Panel, which was established in 1976
with involvement and support from the FDA and the Consumer Federation
of America.
Today, CIR is the only scientific program in the world dedicated to
a thorough and continuous review of cosmetic ingredient safety in a
public forum. The CIR Expert Panel, which meets in public in
Washington, DC four times a year, is an independent, non-profit body of
world-renowned physicians and scientists who examine and assess
cosmetic ingredient safety data in an open, public manner. Their work
is critical to our industry. The FDA and the Consumer Federation of
America, along with the Council, serve as non-voting members of CIR and
play a valuable role in the deliberations. These reviews define safe
ranges for ingredients used in products, and each ingredient report
often involves the panel's scrutiny of hundreds of studies. CIR has
also evaluated the safety of certain cosmetic ingredients at the
request of FDA and all of its findings are published in the peer-
reviewed scientific journal, The International Journal of Toxicology.
In addition, the cosmetic industry plays a unique role in the lives
of American families and is committed to enhancing their lives in a
number of ways. We are a major source of high-paying manufacturing and
management jobs and are committed to a diverse workforce. Our companies
employ more women and people of color in management positions than the
national average.
Women and people of color account for nearly 74 percent of all
employment in the personal care products sector and 61.2 percent of
management positions. We support a wide range of corporate and social
programs, issues and causes that make our communities better places to
live.
Council member companies that are direct sellers like Avon, Mary
Kay, and Amway, among others, offer strong entrepreneurial
opportunities for women across America--opportunities that allow for
personal growth and economic freedom.
We look forward to working with Congress and key stakeholders--as
we have for nearly a decade--to modernize FDA's regulatory authority
over our industry. We support the creation of a national standard that
maintains the continued safety of our products while providing the
Agency with the resources it needs to offer peace of mind to the
families who trust and rely on our products every day. Despite this
strong safety record, a comprehensive national program is needed to
assure uniform regulation of cosmetics throughout the country and to
prevent an unworkable patchwork of differing State requirements across
the Nation. We also believe that a strong national standard will give
businesses the certainty they need to continue to innovate and provide
consumers access to both legacy brands and the new, exciting and safe
products they have come to expect.
We also support mandatory registration with FDA of manufacturing
facilities and ingredient statements; authorizing FDA to issue Good
Manufacturing Practices for cosmetics; reporting to FDA serious adverse
events; and creation of a program for FDA to review the safety of
cosmetic ingredients.
In summary, our work and that of our members is based on sound
scientific principles. Our industry puts consumer safety first, and we
will continue to proactively work to ensure the products we manufacture
contribute to the well-being of American consumers.
Thank you for the opportunity to be here today. On behalf of the
members of the Personal Care Products Council, we look forward to
working with Congress to move reform forward.
The Chairman. Thank you, Dr. Jonas.
Dr. Bergfeld.
STATEMENT OF WILMA BERGFELD, M.D., SENIOR DERMATOLOGIST AND
EMERITUS DIRECTOR OF DERMATO-
PATHOLOGY, DIRECTOR OF DERMATOPATHOLOGY FELLOWSHIP, AND
PROFESSOR OF DERMATOLOGY AND PATHOLOGY DEPARTMENTS OF
DERMATOLOGY AND PATHOLOGY AT CLEVELAND CLINIC, AND CHAIR OF
COSMETIC INGREDIENT REVIEW, CLEVELAND, OH
Dr. Bergfeld. Thank you, Chairman Alexander, Senator
Murray, and distinguished members of the committee. Thank you
for the opportunity to be here on behalf of the Cosmetic
Ingredient Review Expert Panel, often referred to as the CIR.
My name is Dr. Wilma Bergfeld. I am a senior dermatologist,
emeritus director of Dermatopathology, director of Dermato-
pathology Fellowship, and professor of dermatology and
pathology at the Cleveland Clinic, and I am also an associate
clinical professor in the Department of Dermatology at Case
Western Reserve University. I am a board certified
dermatologist and dermato-
pathologist, and hold an M.D. from Temple University School of
Medicine in Philadelphia.
I have been a consultant for the FDA Dermatology and
Ophthalmology Advisory Committee since 1973, including serving
as chair for two 4-year sessions. I am currently the chair of
the CIR, which is a panel of nine voting members and three
liaison members.
This distinguished group is comprised of world-renowned
dermatologists, toxicologists, chemists, consumer protection
advocates, public health experts, and FDA representatives who
have all been publicly nominated by consumer groups, scientific
and medical groups, government agencies, and the industry.
For 40 years, the CIR has reviewed the safety of cosmetic
ingredients in the United States, and our mission to protect
consumers remains strong. Public safety is our major
consideration.
Established in 1976 with support from the FDA and the
Consumer Federation of America, the CIR Expert Panel thoroughly
reviews and assesses the safety of ingredients used in
cosmetics in an open and expert manner. CIR meets quarterly and
our work is fully transparent and available to the public, FDA,
CFA, and industry participants in the public deliberations
regarding ingredient safety.
CIR develops safety assessments of monograph published
works, and this work is published in the peer-reviewed
International Journal of Toxicology, and issues an annual
comprehensive collection of all CIR reports, including
abstracts, discussions, and conclusions.
We solicit public comment at all stages of the multi-
layered process.
As of June 2015, the CIR Expert Panel has reviewed more
than 4,000 cosmetic ingredients, classifying them as follows:
safe as used, safe with certain use restrictions, unsafe for
use in cosmetics, or insufficient data available to assess
safety of use in cosmetics.
Approximately 95 percent of the ingredients reviewed were
considered safe as used or safe with use restrictions. A
portion of those ingredients were not deemed safe until
additional data was provided. Less than one-half of 1 percent
were considered unsafe for use.
The CIR recognizes the need for regular evaluation to
ensure the effectiveness of our efforts and our ability to
appropriately complement the FDA's work.
For this reason, CIR supports the efforts to modernize the
regulatory structure, which is now more than 70 years old, to
ensure the FDA has the appropriate funding, resources, and
administrative authority to continue to provide effective
oversight of the cosmetics industry.
Thank you.
[The prepared statement of Dr. Bergfeld follows:]
Prepared Statement of Wilma Bergfeld, M.D.
Chairman Alexander, Ranking Member Murray and distinguished members
of the committee, thank you for the opportunity to be here on behalf of
the Cosmetic Ingredient Review Expert Panel, often referred to as CIR.
My name is Dr. Wilma Bergfeld. I am the Senior Dermatologist, Emeritus
Director of Dermatopathology, Director of Dermatopathology Fellowship,
Professor of Dermatology and Pathology at the Cleveland Clinic and an
Associate Clinical Professor in the Department of Dermatology at Case
Western Reserve University. I am a board certified dermatologist and
dermatopathologist and hold an M.D. from Temple University School of
Medicine in Philadelphia. I have authored more than 600 publications, 3
books and 65 book chapters, and serve on many journal editorial boards.
Particularly relevant to today's discussion, I have been a
consultant and member of the Food & Drug Administration's Dermatology
and Ophthalmology Advisory Committee since 1973, including serving as
chair from 1986-88 and 1992-2000. In addition, I have been on the
Orphan Drug Committee, and a member and consultant to the Rheumatology
Advisory Committee, and Device Advisory Committee.
In addition to my work with the FDA, I am the current chair of the
CIR Expert Panel--a panel of 9 voting members and 3 liaisons. This
distinguished group is comprised of world-renowned dermatologists,
toxicologists, chemists, consumer protection advocates, public health
experts and FDA representatives who have been publicly nominated by
consumer, scientific and medical groups, government agencies, and
industry. Some of CIR's panel members also serve on international
standards groups. I have served as Chair of CIR for the past 26 years.
For 40 years, CIR has reviewed the safety of cosmetics ingredients
in the United States, and our mission to protect consumers remains
strong. As a dermatologist, I know that every day, millions of American
families use cosmetics and personal care products, but they may not be
aware of the significant efforts behind the scenes to ensure product
safety.
Established in 1976 with support from the FDA and the Consumer
Federation of America, the CIR Expert Panel thoroughly reviews and
assesses the safety of ingredients used in cosmetics in an open and
expert manner, and publishes the results in peer-reviewed literature.
Although funded by the cosmetics industry, CIR and its review process
are independent. Anonymous peer-review evaluation of all CIR final
reports is a key safeguard of scientific integrity. Each member of the
Expert Panel is required to meet the same conflict-of-interest
standards as those of FDA advisory committee members.
CIR meets quarterly and our work is fully transparent and available
to the public. Meetings are announced in advance and open to the
public. FDA, CFA and industry participate in the public deliberations
regarding ingredient safety. CIR develops safety assessment monographs,
publishes its work in the peer-reviewed International Journal of
Toxicology, and issues an annual comprehensive collection of all CIR
reports, including abstracts, discussions and conclusions.
We solicit public comment at all stages of the multi-review
process. If the open, scientific literature contains insufficient
information or if the information submitted is insufficient to make a
safety determination, CIR will call on industry and other interested
parties to undertake specific studies to address these insufficiencies,
or to provide previously unpublished data. CIR reports and transcripts
of its discussions are freely available for download on the CIR
website. Unpublished studies, used in the Panel's deliberations, are
freely available upon request.
Over the last four decades, CIR has established a strong track
record of protecting the public. As of June 2015, the CIR Expert Panel
has reviewed more than 4,000 cosmetic ingredients, classifying them as
either safe as used, safe with certain use restrictions, unsafe for use
in cosmetics, or insufficient data available to assess safety of use in
cosmetics. Approximately 95 percent of the ingredients reviewed were
considered safe as used or safe with use restrictions. A portion of
those ingredients were not deemed safe until additional data was
provided. Less than one-half of 1 percent (0.4 percent) were considered
unsafe for use.
While most consumers may not know that CIR exists, they have in
fact relied on our objectivity and expertise for 40 years. I take great
pride in the work we do and I am privileged to serve with such a
renowned group of experts. Nevertheless, we recognize the need for
regular evaluation to ensure the effectiveness of our efforts and our
ability to appropriately complement FDA's work.
For this reason, we are in support of efforts to modernize the
regulatory structure, which is now more than 70 years old, in order to
ensure FDA has the appropriate funding, resources and administrative
authority to continue to provide effective oversight of the cosmetics
industry.
Thank you for the opportunity to be with you today and to talk
about the important work of the Cosmetic Ingredient Review Expert
Panel.
The Chairman. Thank you, Dr. Bergfeld.
Mr. Faber.
STATEMENT OF SCOTT FABER, J.D., SENIOR VICE PRESIDENT OF
GOVERNMENT AFFAIRS, ENVIRONMENTAL WORKING GROUP, WASHINGTON, DC
Mr. Faber. Thank you, Mr. Chairman. Thank you very much for
holding this hearing and for the opportunity to testify.
Let me start by thanking Senator Collins and Senator
Feinstein for bringing together leaders from industry, from
both large companies and small companies, as well as public
health leaders, to craft a compromise legislation that will
boost consumer confidence in the safety of cosmetics.
A lot has changed since Congress last enacted cosmetics
legislation, and the law passed in 1938 to regulate, in the
words of the statute, ``filthy or putrid products'' is badly
out of date.
Today, the cosmetics industry is a $62 billion industry
that employs 56,000 people who combine thousands of chemicals
and other ingredients to create the essential products we use
every day. While most of the chemicals in cosmetics and other
personal care products likely pose little or no risk, repeated
use of some of these chemicals has been linked to serious
health problems, as we've heard.
In particular, some cosmetic chemicals mimic or block
hormones. These endocrine-disrupting chemicals have been linked
by the National Institute for Environmental Health Sciences to
reduce fertility, to early puberty, and to increases in some
diseases, including some cancers.
Some cosmetic products also pose acute risks, like
infections or allergic reactions, or, as we've heard, hair
loss.
Last week, I got to spend a day on Capitol Hill with one of
the users of WEN shampoo, a very brave little girl named
Eliana, the little girl you've heard about.
Only weeks after she started using Chaz Dean's WEN shampoo,
Eliana lost all of her hair, even her eyelashes. The only thing
she wanted for her 10th birthday was a wig.
To ensure the safety of these products, we believe FDA
should have the authority to quickly review and, if warranted,
restrict chemicals of greatest concern. In addition, FDA should
know more about which chemicals are in these products, should
have access to company safety records, and ensure that products
are being produced in a clean environment so they are not
contaminated.
Consumers should also be able to know more about these
products, including fragrance ingredients. When products do
harm consumers, as it did in the case of Eliana, companies
should be required to quickly notify FDA. If bad actors
continue to produce dangerous products, FDA should have the
power to act.
Other FDA regulated products--food, devices, drugs--are
already subject to these common-sense rules. Other chemicals
routinely used in consumer products, whether it is chemicals in
cleaners, paints, pesticides, toys, are also subject to review
by Federal agencies. Our largest trading partners, Canada and
the European Union, already subject chemicals and cosmetics to
government restrictions.
Certainly, self-regulatory programs can help supplement FDA
oversight, but they are no substitute for FDA review of
chemicals of concern. These programs lack many of the tools
that agencies like FDA would have. Perhaps most importantly,
companies are not obligated to follow their recommendations.
Americans overwhelmingly support Federal oversight of
cosmetics and other personal care products. In fact, recent
polling shows that most Americans believe that these products
are already subject to FDA review. Thanks to the leadership of
Senator Collins and Senator Feinstein, we have a bipartisan
blueprint to finally give these products greater FDA oversight.
I look forward to working with you to craft a modern,
science-based system that ensures the safety of these everyday
products.
Thank you, and I look forward to your questions.
[The prepared statement of Mr. Faber follows:]
Prepared Statement of Scott Faber, J.D.
summary
We strongly support efforts to create a science-based
regulatory system for cosmetics.
The cosmetics industry has grown dramatically since 1938,
when Congress last enacted cosmetics legislation.
While most chemicals in cosmetics pose little or no risk,
some chemicals have been linked to serious health problems, including
chemicals that disrupt the hormone system.
Some cosmetic chemicals also pose acute risks, such as
hair loss and infections.
Under the 1938 law, FDA has little authority to review
chemicals in cosmetics and other personal care products. To date, FDA
has only banned or restricted nine chemicals due to safety concerns.
By contrast, FDA, EPA and CPSC have broad authority to
ensure the safety of chemicals in other consumer products, including
food, drugs, biologics, medical devices, cleaners, paints, solvents,
pesticides, and children's products.
By contrast, our trading partners have taken steps to
ensure the safety of cosmetics.
Industry self-regulation of cosmetic chemicals is not
sufficient to protect consumers.
Self-regulatory bodies lack important data about chemical
use and toxicity, and tend to overlook long-term health risks. In
addition, some findings by self-regulatory bodies have been
inconsistent with findings by government regulatory bodies and experts.
Consumers strongly support greater FDA oversight of
cosmetics, and most consumers believe cosmetic chemicals are already
subject to FDA review.
Under the 1938 law, FDA lacks the basic tools needed to
ensure cosmetic safety, including registration, records access, Good
Manufacturing Practices, and adverse event reporting. FDA cannot
suspend production or recall unsafe products.
By contrast, food, drug and device manufacturers are
subject to basic rules, including registration, records access and
adverse event reporting. FDA has the power to suspend the production of
unsafe food, drugs and devices, and can recall unsafe food and devices.
We urge Congress to create a science-based regulatory
system for cosmetics, including:
FDA review of cosmetic chemicals of concern.
Facility registration, ingredient statements,
records access, and Good Manufacturing Practices.
Adverse event reporting.
Greater transparency about cosmetic ingredients,
including fragrance chemicals.
Adequate resources to review chemicals of concern
and to carry out other responsibilities, such as reviewing
adverse event reports.
A well-crafted regulatory system must promote innovation
and recognize differences between large and small companies.
______
Thank you for the opportunity to provide testimony. My name is
Scott Faber and I am Senior Vice President for Government Affairs for
the Environmental Working Group, which has been evaluating the safety
of personal care product chemicals for more than a decade. EWG's Skin
Deep, our online consumer guide to personal care products, rates the
safety of more than 62,000 products and 8,600 ingredients. Over the
past 5 years, 22 million consumers have visited Skin Deep to learn
about personal care products, and dozens of personal care product
companies, both large and small, consult EWG's safety criteria as they
formulate their products.
Consumers use a wide variety of personal care products, including
cosmetics. Few consumer products contribute as many chemical exposures
as cosmetics and other personal care products. Each day, American women
use an average of 12 personal care products that contain 168 different
chemicals. Men use an average of six personal care products that
contain 85 different chemicals.\1\
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\1\ Environmental Working Group [hereinafter EWG], Exposures Add
Up-Survey Results (2004), http://www.ewg.org/skindeep/2004/06/15/
exposures-add-up-survey-results/.
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While most cosmetic chemicals likely pose little or no risk to
human health, exposure to some chemicals used in cosmetics and other
personal care products has been linked to serious health problems,
including cancer and reproductive harm. Chemicals found in cosmetics
and other personal care products that have been linked to health
problems include phthalates,\2\ parabens,\3\ methylisothiazo-linone,\4\
lead acetate,\5\ triphenyl phosphate,\6\ and formaldehyde \7\ and
chemicals designed to release formaldehyde.\8\ Some chemicals pose
risks at low doses.\9\ In addition to risks posed to consumers, hair
and nail salon workers are especially susceptible to cosmetic chemical
exposures.\10\
---------------------------------------------------------------------------
\2\ See Comm. on the Health Risks of Phthalates, Nat'l Research
Council of the Nat'l Acad., Phthalates & Cumulative Risk Assessment:
The Tasks Ahead (2008), http://www.nap.edu/catalog/12528.html.
\3\ See European Comm'n Sci. Comm. on Consumer Safety, Opinion on
Parabens, Doc. No. SCCS/1348/10 (Dec. 2010, revised March 2011), http:/
/ec.europa.eu/health/scientific_committees/consumer_safety/docs/
sccs_o_041.pdf.
\4\ See M.P. Castanedo-Tardana & K.A. Zug, Methylisothiazolinone,
Dermatitis (Jan.-Feb. 2013), http://www.ncbi.nlm.nih.gov/pubmed/
23340392.
\5\ See The European Comm'n Sci. Comm. on Cosmetic Prods. & Non-
Food Prods. Intended for Consumers, Opinion Concerning Lead Acetate,
Doc. No. SCCNFP/0832/04 (July 2014), http://ec.europa.eu/health/
ph_risk/committees/sccp/documents/out286_en.pdf.
\6\ See Emma Mendelsohn et al., Nail Polish as a Source of Exposure
to Triphenyl Phosphate, 86 Env't Int'l 45-51 (2016), http://
www.sciencedirect.com/science/article/pii/S0160412015
300714; see also EWG, Nailed: Nail Polish Chemical Doubles as Furniture
Flame Retardant (2015), http://www.ewg.org/research/nailed/nail-polish-
chemical-doubles-furniture-fire-retardant.
\7\ See Nat'l Toxicology Program, Report on Carcinogens (13th ed.
2014), https://ntp.niehs.nih.gov/ntp/roc/content/profiles/
formaldehyde.pdf.
\8\ See Anton DeGroot et al., Formaldehyde-Releasers in Cosmetics:
Relationship to Formaldehyde Contact Allergy, 61 Contact Dermatitis 63-
85 (2009), http://www.ncbi.nlm.nih.gov/pubmed/19706047.
\9\ See Laura N. Vandenberg et al., Hormones & Endocrine-Disrupting
Chemicals: Low-Dose Effects & Nonmonotonic Dose Responses, 33 Endocrine
Rev. 378-455 (2012), http://www.ncbi.nlm.nih.gov/pubmed/22419778.
\10\ See, e.g., Sarah Maslin Nir, Perfect Nails, Poisoned Workers,
N.Y. Times, May 8, 2015, http://www.nytimes.com/2015/05/11/nyregion/
nail-salon-workers-in-nyc-face-hazardous-chemicals.html?_r=0;
Occupational Safety & Health Admin., Safety and Health Tips: Hair
Salons, Facts About Formaldehyde in Hair Products, https://
www.osha.gov/SLTC/hairsalons/protecting_worker_health.html (last
visited Sept. 19, 2016).
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Certain chemicals can interfere with the hormone system, and some
of these ``endocrine-disrupting'' chemicals are found in personal care
products. Chemicals like phthalates and triphenyl phosphate can disrupt
the hormone system by mimicking or blocking a natural hormone. When an
endocrine-disrupting chemical mimics a hormone, the chemical tricks the
hormone's receptor into thinking the chemical is the hormone. When the
chemical blocks a hormone, the chemical can bind to a receptor and the
hormone may not be activated.
Endocrine-disrupting chemicals pose unique risks to vulnerable
populations, such as pregnant women and infants, for whom the impacts
may take years to appear. Research shows that endocrine-disrupting
chemicals may pose the greatest risk during prenatal and early
postnatal development, when organ and neural systems are forming. \11\
Exposure to these chemicals has been linked to endocrine diseases
including diabetes and some types of cancer. \12\
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\11\ See Nat'l Inst. of Envtl. Health Sci., Endocrine Disruptors,
https://www.niehs.nih.gov/health/topics/agents/endocrine/index.cfm
(last visited September 19, 2016).
\12\ See Andrea C. Gore et al., Executive Summary to EDC-2: The
Endocrine Society's Second Scientific Statement on Endocrine-Disrupting
Chemicals, 36 Endocrine Rev. 593-602 (2015), http://
press.endocrine.org/doi/10.1210/er.2015-1093.
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Some chemicals in cosmetics and other personal care products also
pose acute risks. Formaldehyde-based hair straightening procedures,
referred to as ``keratin treatments,'' have been linked to hair loss,
rashes, blisters, nosebleeds, bleeding gums, and loss of taste and
smell.\13\ Thousands of women and girls recently reported losing some
or all of their hair after using a shampoo promoted by a celebrity hair
stylist.\14\ Some skin lightening creams contain mercury.\15\ If
produced in unsanitary conditions, products--including shampoos, shower
gels, makeup and mouthwash--can become contaminated with bacteria and
mold, and cause serious harm, including infections.\16\ For example,
two baby wipe companies recently manufactured products contaminated
with bacteria.\17\
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\13\ See EWG, Brazilian-Style Blowouts: Still Poisonous, Still in
Salons (2015), http://www.ewg.org/enviroblog/2015/08/brazilian-style-
blowouts-still-poisonous-still-salons.
\14\ See Eric Lipton & Rachel Abrams, Their Hair Fell Out. Should
the F.D.A. Have the Power to Act? N.Y. Times, Aug. 15, 2016, http://
www.nytimes.com/2016/08/16/us/politics/cosmetics-industry-congress-
regulation-wen.html?_r=0.
\15\ See U.S. Food & Drug Admin., Consumer Updates: Mercury
Poisoning Linked to Skin Products, http://www.fda.gov/downloads/
ForConsumers/ConsumerUpdates/UCM294876.pdf (last updated July 26,
2016).
\16\ See U.S. Food & Drug Admin., Warning Letters Cite Cosmetics as
Adulterated Due to Microbial Contamination, http://www.fda.gov/
Cosmetics/ComplianceEnforcement/WarningLetters/ucm085147.htm (last
updated Mar. 29, 2016).
\17\ See U.S. Food & Drug Admin., Safety Alert: Baby Wipes by Nutek
Disposables, Inc.: Recall--May Contain Bacteria (Oct. 27, 2014), http:/
/www.fda.gov/Safety/MedWatch/Safety
Information/SafetyAlertsforHumanMedicalProducts/ucm420508.htm.
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The Food and Drug Administration (FDA) has little authority to
review or restrict chemicals in cosmetics.\18\ In general, substances
used in cosmetics and other personal care products are not subject to
review or regulation by FDA, and few have been restricted. Under
current law, FDA can only restrict chemicals that render the product
``adulterated,'' and FDA has only banned or restricted nine ingredients
under this authority.\19\ Only products that pose acute risks, such as
contaminated products, are ``adulterated'' and FDA must work with the
Department of Justice to demonstrate that a product meets this
test.\20\ By contrast, many chemicals in cosmetics have been restricted
by our trading partners in Canada, Japan and the European Union.\21\
For example, the use of certain parabens linked to hormone disruption
is restricted in the European Union--especially in products intended
for use on infants--but there are no such restrictions in the United
States.\22\
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\18\ See 21 U.S.C. 361-63.
\19\ See 21 CFR 700.11 et seq. In addition, chlorofluorocarbon
propellants are prohibited for use in cosmetic products under the Clean
Air Act (21 CFR 2.125), and the labeling of products containing
sunscreens to protect the cosmetic's color but not the user from the
sun is regulated (21 CFR 700.35).
\20\ 21 U.S.C. 361.
\21\ See Valerie J. Watnick, The Missing Link: U.S. Regulation of
Consumer Cosmetic Products to Protect Human Health and the Environment,
31 Pace Envtl. L. Rev. 595 (2014), http://digitalcommons.pace.edu/pelr/
vol31/iss3/1 (discussing Canada, the European Union, and Japan's
oversight of cosmetics).
\22\ See European Commission Press Release IP/14/1051, Consumers:
Commission Improves Safety of Cosmetics (Sept. 26, 2014), http://
europa.eu/rapid/press-release_IP-14-1051_en.
htm.
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FDA and other agencies have broad authority to review and regulate
chemicals found in other consumer products. For example, FDA has the
authority to review chemicals in prescription \23\ and over-the-counter
drugs \24\ and chemicals found in food.\25\ The Environmental
Protection Agency (EPA) has the authority to review chemicals in
pesticides used in our homes and on farms \26\ and to set limits for
pesticide residues on food.\27\ This year, Congress expanded EPA
authority to review chemicals in cleaners, paints, solvents and many
other consumer products.\28\ The Consumer Product Safety Commission
(CPSC) has the authority to develop standards and bans for many
consumer products.\29\ Updates to the Consumer Product Safety Act gave
CPSC specific authority to set content limits for lead in children's
products, paint and electronic devices,\30\ promulgate standards for
durable infant or toddler products,\31\ limit toxic substances in
toys,\32\ and ban certain phthalates in children's products.\33\
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\23\ See 21 U.S.C. 351-360fff.
\24\ See 21 CFR 330.
\25\ 21 U.S.C 348.
\26\ See 7 U.S.C. 136a-136d.
\27\ 21 U.S.C. 346a.
\28\ See 15 U.S.C. 2604-05.
\29\ See 15 U.S.C. 2051-2089.
\30\ 15 U.S.C. 1278a.
\31\ 15 U.S.C. 2056a.
\32\ 15 U.S.C. 2056b(b)(1)(B).
\33\ 15 U.S.C. 2057c.
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FDA and other agencies also have broad authority to collect data on
chemicals found in consumer products. When FDA reviews food chemicals,
for example, it requires the submission of certain safety and use
data.\34\ EPA also has broad authority to require safety data on
chemicals used in industrial and consumer products. This year, Congress
gave EPA broader authority to obtain new information about
chemicals.\35\ For pesticides, EPA has guidelines specifying what kind
of data must be included with a pesticide registration.\36\ CPSC has
specific authority to require any manufacturer of a consumer product to
submit data.\37\
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\34\ 21 U.S.C. 348(b).
\35\ 15 U.S.C. 2603(a)(2).
\36\ 7 U.S.C. 136a(c)(2); 40 CFR 158. See also Office of
Pesticide Programs, U.S. Envtl. Prot. Agency, Guiding Principles for
Data Requirements (May 31, 2013), https://www.epa.gov/sites/production/
files/2016-01/documents/data-require-guide-principle.pdf.
\37\ 15 U.S.C. 2076(e).
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Industry self-regulation of cosmetic ingredients is not sufficient
to protect consumers from health risks. Industry-financed review
programs may supplement but should not substitute government regulatory
programs governed by minimum standards for collection and review of
chemical exposure and toxicity data. These self-regulatory programs
lack the same access to data about chemical use and toxicity as
government regulators. As a result, these bodies may fill gaps in data
by assuming very large groups of structurally similar chemicals have
the same impacts on human health.\38\ What's more, cosmetic formulators
have no obligation to abide by self-regulatory program
recommendations,\39\ and these recommendations frequently lack specific
limits or instructions on chemical use, manufacture or processing.\40\
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\38\ See, e.g., Cosmetic Ingredient Review [hereinafter CIR],
Expert Panel 135th Meeting Findings (June 2015), http://www.cir-
safety.org/sites/default/files/062015PMA-v3.pdf (Polysaccharide Gums,
106 ingredients); CIR, Expert Panel 126th Meeting Findings (Mar. 2013),
www.cir-safety.org/sites/default/files/
March%20postmeeting%20announcement%20-revised.pdf (Alkyl Esters, 237
ingredients).
\39\ For example, a formulator sold an adulterated product
containing an ingredient that CIR had found unsafe for the product's
use. See Warning Letter from Susan M. Turcovski, District Director,
Florida District Office, U.S. Food & Drug Admin., to Mr. Van Tibolli,
CEO, Van Tibolli Beauty Corp. (Sept. 2, 2015), http://www.fda.gov/
ICECI/EnforcementActions/WarningLetters/2015/ucm462375.htm.
\40\ See, e.g., CIR, Amended Safety Assessment of
Methylisothiazolinone as Used in Cosmetics (2014) (concluding that an
allergenic ingredient that ought to be restricted to a specific
concentration in products to be rinsed off could be permitted at any
concentration in products intended to remain on the skin, so long as
the formulator makes the product ``non-sensitizing'').
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Self-regulatory bodies may overlook long-term health risks in favor
of short-term risks. In general, self-regulatory programs tend to focus
on short-term effects, such as allergic reactions, and lack the
capacity to review health impacts from chronic exposures. Substances
such as endocrine-disrupting chemicals may cause health effects that
will not be apparent for many years.\41\ In addition, some self-
regulatory panels incorrectly assume that exposures to chemicals in
cosmetics are too low to impact health. For example, some panels have
improperly asserted that exposures via routes such as inhalation cannot
occur.\42\
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\41\ See Vandenberg, supra note 9.
\42\ See, e.g., CIR, Safety Assessment of Alkyl PEG/PPG Ethers
(2013) (concluding ``in the absence of inhalation toxicity data'' that
the chemical ``can be used safely in aerosol products''); CIR, Amended
Safety Assessment of [Coconut Oil, etc.] (2008), http://www.cir-
safety.org/sites/default/files/115_buff3e_suppl.pdf (finding coconut
oil ``can be used safely in hair products,'' without inhalation
toxicity data). CIR panels have underestimated inhalation risks in the
past. See CIR, Transcript: 120th CIR Expert Review Panel Meeting 64
(Sep. 26, 2011), http://www.cir-safety.org/sites/default/files/092711-
CIR%20PANEL.pdf.
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Some findings by industry self-regulatory bodies are inconsistent
with findings by other regulatory authorities or experts. For example,
methylisothiazolinone,\43\ iodopropynyl butylcarbamate \44\ and
methyldibromo glutaronitrile \45\--preservatives deemed too risky for
certain uses by other authorities--were found safe for use at higher
concentrations or without similar restrictions by industry panels. Two
hair dye chemicals that have been linked to health problems by Canadian
regulators and the National Toxicology Program (NTP), respectively,
have been deemed ``safe as used'' as well.\46\ Another chemical is used
in fragrance without restriction, even though an NTP study found it is
a likely carcinogen.\47\
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\43\ CIR found methylisothiazolinone (MI), an allergen, safe for
use in rinse-off products at concentrations up to 100 PPM and simply
instructs manufacturers to formulate leave-on products so that they do
not cause allergic reactions. CIR, Amended Safety Assessment of
Methylisothiazolinone as Used in Cosmetics (2014). In contrast, MI
concentration is restricted to 0.01 percent in Canada. Health Canada,
Cosmetic Ingredient Hotlist, http://www.hc-sc.gc.ca/cps-spc/cosmet-
person/hot-list-critique/hotlist-liste-eng.php#m1 (last updated Dec.
14, 2015). The EU permits MI at 15 ppm in rinse-off, but no MI in
leave-on products. European Comm'n, Ingredient: Methylisothiazolinone,
http://ec.europa.eu/growth/tools-databases/cosing/index.
cfm?fuseaction=search.details_v2&id=35341 (last visited Sept. 19,
2016).
\44\ The European Commission restricted use of iodopropynyl
butylcarbamate (IPBC) in cosmetics. Companies cannot use it in lip
products due to concerns about ingestion, or in lotion or other
products that cover a large area of the body, because IPBC may
contribute to unsafe levels of iodine in the body. All IPBC-containing
cosmetics must bear a warning: ``Not to be used for children under 3
years of age.'' European Comm'n, Substance: 3-Iodo-2-propynylbutylcarba
mate, http://ec.europa.eu/growth/tools-databases/cosing/
index.cfm?fuseaction=search.details_
v2&id=31086 (last visited Sept. 19, 2016). However, CIR in 2013
reconfirmed the preservative ``safe as used in cosmetics at
concentrations [less than or equal to] 0.1%,'' declining to reopen its
1998 decision and setting no special restrictions to protect children.
CIR, Cosmetic Ingredient Review Expert Panel 128th Meeting (September
9-10, 2013)--Findings (Sept. 2013), http://www.cir-safety.org/sites/
default/files/Sept2013%20postmeeting%20announcement.pdf (reaffirming
its earlier conclusion); CIR, Final Report on the Safety Assessment of
Iodopropynyl Butylcarbamate (IPBC) (July 1998).
\45\ The European Commission found that there was no safe level of
use for methyldibromo glutaronitrile (MDGBN), another allergen.
European Comm'n Sci. Comm. on Consumer Prods., Opinion on
Methyldibromoglutaronitrile (June 2006), http://ec.europa.eu/health/
ph_risk/committees/04--sccp/docs/sccp_o_060.pdf. But CIR found MDBGN is
safe as used in rinse-off cosmetics, and safe at levels up to 0.025
percent in leave-on products. CIR, Final Report on the Safety
Assessment of Methyldibromo Glutaronitrile (1996).
\46\ Canada recently set a maximum concentration of 3 percent for
p-phenylenediamine in hair dyes. Health Canada, Cosmetic Ingredient
Hotlist, http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-
critique/hotlist-liste-eng.php#m1 (last updated Dec. 14, 2015). In
2007, CIR determined it ``safe as used,'' noting it was in use at
concentrations ranging between 2-4 percent in almost 1,500 products.
CIR, Safety Assessment of p-Phenylenediamine, p-Phenylenediamine HC1,
and p-Phenylenediamine Sulfate (Dec. 2007). The National Toxicology
Program has found Disperse Blue 1 as ``reasonably anticipated to be a
human carcinogen,'' but CIR found the chemical safe for use in hair
dye, at levels up to 1 percent. Compare Nat'l Toxicology Program,
Report on Carcinogens: Disperse Blue 1 (13th ed. Oct. 2014), http://
ntp.niehs.nih.gov/ntp/roc/content/profiles/disperseblue1.pdf with CIR,
Final Report on the Safety Assessment of Disperse Blue 1 (1995).
\47\ In 2014, the National Academy of Science's National Research
Council endorsed a 2011 finding by the National Toxicology Program that
styrene is ``reasonably anticipated to be a human carcinogen.'' Comm.
to Rev. the Styrene Assessment in the Nat'l Toxicology Program 12th
Report on Carcinogens, Nat'l Research Council, Review of the Styrene
Assessment in the National Toxicology Program 12th Report on
Carcinogens (2014), https://www.nap.edu/catalog/18725/review-of-the-
styrene-assessment-in-the-national-toxicology-program-12th-report-on-
carcinogens. Although the International Fragrance Association (IFRA)
suggests restrictions for some chemicals, IFRA suggests no limits for
styrene. Int'l Fragrance Ass'n, Ingredients, http://www.ifraorg.org/en-
us/ingredients#.V-A1cpMrKLI (last visited Sept. 19, 2016); Int'l
Fragrance Ass'n, Standards, http://www.ifraorg.org/en-us/standards#.V-
A555MrIxf (last visited Sept. 19, 2016).
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Consumers overwhelmingly support Federal oversight of cosmetic
chemicals. Recent polling conducted by American Viewpoint and the
Mellman Group found that two-thirds of consumers believe chemicals in
cosmetics are already reviewed by FDA.\48\ Three-fourths of consumers--
regardless of age, race or party affiliation--support stricter
oversight of chemicals in cosmetics and nearly nine-in-ten consider
stricter rules very important. In addition, nine-in-ten consumers
believe cosmetic companies should have to notify FDA if their products
harm consumers, support giving FDA mandatory recall authority, and
support rules ensuring cosmetics are produced in clean environments.
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\48\ Mark Mellman & Linda DiVall, Findings From a National Survey
of Likely 2016 General Election Voters (Feb. 2016), https://
cdn.ewg.org/sites/default/files/u381/cosmetics.pdf?_ga=
1.55566627.92668946.1470953450.
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FDA lacks the basic tools needed to ensure the safety of cosmetics
and other personal care products. Under current law, cosmetic companies
do not have to register with FDA, submit cosmetic ingredient
statements, adopt good manufacturing practices, provide access to
safety records, report adverse events, or share the cost of a modern
regulatory system. FDA also lacks the authority to quickly suspend
production or recall contaminated products when a company fails to
initiate a voluntary recall.
By contrast, food, prescription drug, over-the-counter drug and
medical device manufacturers are subject to basic rules. Food, drug and
device manufacturers must register their facilities with FDA \49\;
maintain and give FDA access to records \50\; and report any adverse
events to FDA.\51\ Drugs, devices and biologics cannot be sold without
prior FDA approval, including approval of a product's ingredients.\52\
If food, drugs or devices are unsafe, FDA can suspend production and
product licenses.\53\ When unsafe food, drugs and devices do reach the
market, FDA can order recalls of food, biologics and devices, and can
take legal action against drug makers who do not recall their
products.\54\
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\49\ 21 U.S.C. 350(d) (food); 21 CFR 807 (devices); 21 U.S.C.
360 (drugs); 21 CFR 607.65, 1271 (biologics).
\50\ 21 U.S.C. 350(c) (food); 21 CFR 211 (drugs); 21 CFR
820.180 (devices); 21 CFR 600.12 (biologics).
\51\ 21 U.S.C. 350(d) (food); 21 CFR 310.305(c)(1);
314.80(c)(1)(i); 314.98(a) (drugs); 21 CFR 803.1 (devices); 21 CFR
600.80(c)(1)(i) (biologics).
\52\ 21 CFR 314 (drugs); 21 CFR 814 (devices); 21 CFR 601.2
(biologics).
\53\ 21 U.S.C. 350(d) (food); 21 CFR 1.94 (drugs); 21 U.S.C.
334 (devices); 21 CFR 601.6 (biologics).
\54\ 21 U.S.C. 350(l) (food); 42 U.S.C. 262 (biologics); 21 CFR
5.411 (biologics); See also U.S. Food & Drug Admin., FDA Basics: Why
Isn't a Drug Taken Off the Market When a Manufacturer Gets a Warning
Letter?, http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194988.htm
(last updated Sept. 11, 2016).
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The personal care products industry has grown dramatically since
Congress enacted current cosmetics law almost 80 years ago. When
Congress enacted the Food, Drug, and Cosmetics Act in 1938, the
cosmetics industry generated approximately $1 billion in sales.\55\
Today, the cosmetics industry generates $62 billion in annual revenue,
employing more than 56,000 people. \56\ Simply put, cosmetics law has
not kept pace with changes in regulatory science and consumer
expectations. A law enacted in 1938 to prohibit the use of ``filthy,
putrid, or decomposed'' substances is woefully out of date. In
particular, current law remains too focused on short-term injuries,
such as infections, while largely ignoring the cumulative effects of
repeated exposures over many years.
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\55\ Kerry A Harnett, Appearing Modern: Women's Bodies, Beauty &
Power in 1920's America 69 (April 2009) (Honors dissertation, Boston
College), https://dlib.bc.edu/islandora/object/bc-ir:102409/datastream/
PDF/view.
\56\ Statista, Revenue of the Cosmetics Industry in the United
States from 2002-2016, https://www.statista.com/statistics/243742/
revenue-of-the-cosmetic-industry-in-the-us/ (last visited Sept. 19,
2016).
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Congress must create a modern regulatory program for cosmetics and
other personal care products, as proposed in S. 1014. A modern
regulatory program would give FDA the power to review cosmetic
chemicals of concern, expand FDA's ability to know when contaminated
products threaten public health, respond to rising imports of personal
care products, give FDA the resources to detect and respond to threats
to public health, and grant FDA the power to act when companies decline
to voluntarily recall contaminated products. We believe that well-
crafted, science-based reforms will boost consumer confidence in
personal care products and promote even greater innovation by cosmetic
companies.
As Congress considers steps to modernize cosmetics law, we propose
the following reforms:
Subject Cosmetic Chemicals of Concern to Review--FDA
should have the power to review and regulate cosmetic chemicals of
concern to ensure that these chemicals pose a reasonable certainty of
no harm to human health. Once chemicals of concern have been
identified, FDA should quickly collect data on chemical use and
toxicity to determine whether the chemical is safe or should be subject
to restrictions.
Strengthen Industry Self-Regulatory Programs--Cosmetics
law should clarify the role of industry self-regulatory programs and
clearly establish the duty of cosmetic companies to substantiate the
safety of their products. Industry-financed programs that are not based
upon widely accepted scientific principles should not be the basis upon
which companies can claim that personal care products are safe.
Require Facility Registration, Records Access--Cosmetic
companies should be required to register with FDA, provide FDA with
cosmetic ingredient statements, and be required to provide FDA access
to safety records.
Require Good Manufacturing Practices--To prevent microbial
contamination, cosmetic companies should be required to adopt Good
Manufacturing Practices that will ensure that cosmetics are produced in
safe and clean environments.
Require Adverse Event Reporting, Recall Power--Cosmetic
companies should be required to quickly report serious adverse events
and to frequently provide FDA with all adverse event reports. If a
contaminated product poses serious health risks and a company has
declined to conduct a voluntary recall, FDA should have the power to
order a mandatory recall and to suspend production of contaminated
products.
Expand Disclosure Requirements--Cosmetic companies should
be required to provide consumers more information about cosmetic
chemicals, including fragrance ingredients. Any disclosures required
for cosmetics and other personal care products should apply to sales of
salon products and to sales made through internet retailers.
Provide Adequate Resources--In light of FDA's other
critical responsibilities, FDA must have additional resources to review
cosmetic chemicals of concern and to carry out other regulatory
responsibilities, such as reviewing adverse event reports. Simply
giving
FDA new authorities--and no new resources--would fall
short of consumer expectations.
Promote Innovation--Companies of all sizes can pose
significant health risks. For example, some tattoo inks pose
contamination risks.\57\ However, a well-crafted regulatory system must
recognize differences between large and small companies.
---------------------------------------------------------------------------
\57\ U.S. Food & Drug Admin., Constituent Update: FDA Warns Tattoo
Artists & Consumers Not to Use Certain Tattoo Inks (Aug. 6, 2015),
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm457439.htm.
All of these reforms have been endorsed by the personal care
products industry, including large and small manufacturers. We believe
these are reasonable reforms that will boost consumer confidence in
cosmetics and other personal care products and ensure that these
essential, everyday products are safe. We look forward to working with
you to craft a regulatory system as modern as the personal care
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products industry.
The Chairman. Thank you, Mr. Faber.
Ms. Dandurand, welcome.
STATEMENT OF CURRAN DANDURAND, CEO AND CO-FOUNDER, JACK BLACK
LLC, CARROLLTON, TX
Ms. Dandurand. Good morning, Chairman Alexander and
committee members. My name is Curran Dandurand. I am the CEO of
Jack Black LLC, a company I founded over 16 years ago with my
husband, Jeff, and my colleague Emily Dalton. We founded the
company with our combined lifesavings and a vision of a market
segment that we believed was underserved.
Our company develops and markets quality personal care
products for men under the Jack Black brand name.
When we started, we had no employees. It was just the three
of us operating out of our homes. We are now a market leader,
employ almost 80 people, and have office, distribution, and
warehouse facilities, and a national sales force.
Jack Black is sold in all 50 States and in more than 30
international markets. Virtually all our products and packaging
materials are manufactured here in the United States.
I am here today as a small-business owner. I am also a
member of the Independent Cosmetics Manufacturers and
Distributors Association, a nonprofit trade organization with
over 700 member companies whose mission is to educate and
promote the growth of entrepreneurial companies like mine.
The cosmetics industry is a dynamic stronghold of
entrepreneurial activity, with relatively low barriers to entry
and the opportunity for people from all walks of life to start
a business and grow it into something successful.
When we started our business more than 16 years ago, there
were very few companies that marketed a full line of personal
care products for men. Today, in part due to our own success,
this has changed with many, many more brands competing in this
space. Many of these brands are owned by very large, powerful,
multinational companies with significant advertising and
marketing resources.
For smaller companies like ours that don't have even a
fraction of these resources, the keys to growth are product
innovation, being nimble and highly responsive to our
customers.
Product safety is sacrosanct and a crucial cornerstone in
our brand philosophy.
The first step in our product innovation process is to
conduct an extensive ingredient review of the proposed new
formula, to confirm that the individual ingredients are safe
and the combination of ingredients is safe.
The next step is to have the new formulation tested using
the Human Repeat Insult Patch Test, or HRIPT, and other testing
methodologies that are appropriate depending on the product
type and intended use.
Once a product has passed these tests, we can proceed to
consumer panel testing to confirm product performance and
consumer acceptance.
The other key concern in the product development process is
making certain that the products can be produced within our
cost parameters and that they are fully compliant with the laws
of all jurisdictions in which they will be marketed.
Currently within the United States, and contrary to
regulatory trends in other areas of the world, there has been a
movement to create separate State requirements. These
regulations would be separate and apart from, and inconsistent
with, the Federal standards established by FDA.
Having to comply with potentially 50 different standards on
labeling, ingredient safety, and registration requirements
would be burdensome and impossible for small companies like
ours, even successful ones. Smaller companies do not have the
resources to develop, test, and maintain separate inventories
to meet State requirements, and cannot afford the regulatory
staff needed to navigate myriad diverse State regulations.
It is clear that the erosion of a national standard has and
will continue to substantially increase the cost of producing
and distributing personal care products, with a
disproportionate impact on smaller companies.
Consequences for the small-business owner would be
disastrous. Many would have to stop doing business in States
where they could not afford to comply. Others would go out of
business. Still other businesses would never get started in the
first place.
If this had been the regulatory landscape 16 years ago when
we started Jack Black, we would have had a very difficult time
getting out of the starting gate, much less becoming
successful, and our company would probably not exist today.
The science establishing ingredient safety should not
change from State to State. Therefore, it does not make sense
to allow varying State regulations regarding cosmetic safety
standards.
In addition to the creation of one consistent national
standard, there are other opportunities to improve the existing
regulatory framework for cosmetics, giving the FDA greater
oversight and visibility into the industry to ensure consumer
safety and confidence.
Thank you for providing me the opportunity to appear before
you today, and I would be happy to answer any questions you may
have.
[The prepared statement of Ms. Dandurand follows:]
Prepared Statement of Curran Dandurand
summary
Good morning Chairman Alexander and Ranking Member Murray, my name
is Curran Dandurand. I am the CEO of Jack Black LLC., a company I
founded over 16 years ago with my husband Jeff and my colleague Emily
Dalton. We founded the company with our combined life savings and a
vision of a market segment that we believed was underserved. Our
company develops and markets quality personal care products for men
under the Jack Black brand name. When we started, it was just the three
of us operating out of our homes. We now employ almost 80 people in the
United States and have office, distribution and warehouse facilities,
and a national sales force. Jack Black is sold in all 50 States and in
more than 30 international markets.
I am here today as a small business owner. I am also a member of
the Independent Cosmetics Manufacturers and Distributors Association, a
nonprofit trade organization with over 700 member companies whose
mission is to educate and promote the growth of entrepreneurial
companies like mine. The cosmetics industry is a dynamic stronghold of
entrepreneurial activity, with relatively low barriers to entry and the
opportunity for people from all walks of life to start a business and
grow it into something meaningful.
Product safety is sacrosanct and crucial to our brand's success.
The first step in our product innovation process is to conduct an
extensive ingredient review of the proposed new formula, to confirm
that the individual ingredients are safe and the combination of
ingredients is safe. The next step is to have the new formulation
tested using the Human Repeat Insult Patch Test (HRIPT) and other
testing methodologies that are appropriate depending on the product
type and intended use. Once a product has passed these tests and other
expert reviews, we can proceed to consumer testing.
The other key concern in the product development process is making
certain that the products can be produced within our cost parameters
and that they are fully compliant with the laws of all jurisdictions in
which the product will be marketed. Currently within the United States,
and contrary to regulatory trends in other areas of the world, there
has been a movement to create separate State requirements. Having to
comply with potentially 50 different standards on labeling, ingredient
safety and registration requirements would be extremely burdensome for
small companies like ours, even successful ones. Consequences for the
small business owner would be disastrous: many would have to stop doing
business in States where they could not afford to comply, others would
go out of business, still other businesses would never be started due
to high barriers to entry. The science establishing ingredient safety
should not change from State to State, therefore it does not make sense
to allow varying State regulations regarding cosmetics safety
standards.
In addition to the creation of one consistent National Standard
there are other opportunities to improve the existing regulatory
framework, giving the FDA greater oversight and visibility, without
placing onerous, costly burdens on small business and raising the
barriers to entry for starting new businesses.
Thank you for providing me the opportunity to appear before you.
______
Good morning Chairman Alexander and Ranking Member Murray, my name
is Curran Dandurand. I am the chief executive officer of Jack Black
LLC., a company I founded over 16 years ago with my husband Jeff and my
colleague Emily Dalton. We founded the company with our combined life
savings and a vision of a market segment that we believed was
underserved. Our company develops and markets quality personal care
products for men under the Jack Black brand name.
When we started, it was just the three of us operating out of our
homes. We are now a market leader, employ almost 80 people in the
United States and have office, distribution and warehouse facilities,
and a national sales force. Jack Black is sold in all 50 States and in
more than 30 international markets. Virtually all our products and
packaging materials are manufactured in the United States.
I am here today as a small business owner. I am also a member of
the Independent Cosmetics Manufacturers and Distributors Association, a
nonprofit trade organization with over 700 member companies whose
mission is to educate and promote the growth of entrepreneurial
companies like mine. The cosmetics industry is a dynamic stronghold of
entrepreneurial activity, with relatively low barriers to entry and the
opportunity for people from all walks of life to start a business and
grow it into something meaningful.
When we started our business more than 16 years ago there were very
few companies that marketed a full line of personal care products for
men. Today, and in part due to our own success, this has changed with
many more brands competing in this category. Some of these brands are
owned by large, powerful multinational companies with significant
advertising and marketing resources. For smaller companies like ours
that don't have even a fraction of these resources, the keys to growth
are product innovation, product quality, and being nimble and highly
responsive to our customers.
Product safety is sacrosanct and a crucial cornerstone in our brand
philosophy. The first step in our product innovation process is to
conduct an extensive ingredient review of the proposed new formula, to
confirm that the individual ingredients are safe and the combination of
ingredients is safe. The next step is to have the new formulation
tested using the Human Repeat Insult Patch Test (HRIPT) and other
testing methodologies that are appropriate depending on the product
type and intended use. Once a product has passed these tests and other
internal and external expert reviews, we can proceed to consumer panel
testing to confirm product performance and consumer acceptance.
The other key concern in the product development process is making
certain that the products can be produced within our cost parameters
and that they are fully compliant with the laws of all jurisdictions in
which the product will be marketed. Currently within the United States,
and contrary to regulatory trends in other areas of the world, there
has been a movement to create separate State requirements. These
regulations would be separate and apart from, and inconsistent with,
the Federal standards established by FDA. Having to comply with
potentially 50 different standards on labeling, ingredient safety and
registration requirements would be burdensome and impossible for small
companies like ours, even successful ones. Smaller companies don't have
the resources to develop, test and maintain separate inventories to
meet State requirements and cannot afford the regulatory staff needed
to navigate myriad diverse State regulations.
It's absolutely clear that the erosion of a national standard has
and will continue to substantially increase the cost of producing and
distributing personal care products, with a disproportionate impact on
smaller companies. Consequences for the small business owner would be
disastrous: many would have to stop doing business in States where they
could not afford to comply, others would go out of business, still
other businesses would never get started in the first place. If this
had been the regulatory landscape 16 years ago when we started Jack
Black we would have had a very difficult time getting out of the
starting gate, much less becoming successful, and our company and
product line would probably not exist today.
The science establishing ingredient safety should not change from
State to State, therefore it does not make sense to allow varying State
regulations regarding cosmetics safety standards. Proliferation of
diverse State regulations increases the barriers to entry for
prospective entrepreneurs, and drives up the cost and complexity of
doing business, particularly for small business, without any
corresponding progress in consumer safety.
In addition to the creation of one consistent National Standard
there are other opportunities to improve the existing regulatory
framework without placing onerous, costly burdens on small business.
One is the mandatory registration of all United States and foreign
manufacturing facilities that import products into the U.S. market.
Another is to require all manufacturers to file ingredient statements
for all products they manufacture, and a third would be to require that
all manufacturers, both domestic and international, follow Good
Manufacturing Procedures as established by the FDA. These improvements
will give the FDA stronger oversight over cosmetic safety and greater
visibility and transparency with manufacturers. This will also help
provide a level playing field for our U.S. manufacturers by ensuring
that all manufacturers, including those based outside of the United
States, comply with the same requirements and standards.
Thank you for providing me the opportunity to appear before you. I
would be happy to answer any questions you may have.
The Chairman. Thank you, Ms. Dandurand.
Thanks to each one of you for coming. I have an appointment
that is going to require me to step out for a few minutes.
Senator Cassidy is going to become chairman of the committee
for a while, if you will move over here.
We will ask Senator Collins to begin with her round of
questions, and then we will go to all the Senators for their
questions.
Senator Collins.
Senator Collins. Thank you very much, Mr. Chairman.
I am very interested in the testimony that we just heard
because I think it underscores why we need a national standard,
because if you're going to be selling across State lines, it is
just not feasible to have 50 different approaches to this
issue. We don't do that with over-the-counter medications. We
don't do that with prescription drugs. So I am sympathetic to
that.
I have received a letter from a company in Maine called The
Well Bee, which is a small business in Yarmouth, ME, that
produces cosmetics and other personal care products. She
describes that she is very committed to selling and creating
nontoxic personal care products, but it is difficult for a
small company to know whether the ingredients it is using are
safe.
I would ask Ms. Dandurand whether that is an issue for you
in your manufacture of personal products for men.
Ms. Dandurand. Yes, it's very important. Small companies
have to use outside experts to help us evaluate the
ingredients, evaluate the combination of ingredients, know what
databases to use. There is a lot on the Internet now that we
can refer to.
Ultimately, you have to engage experts, toxicology experts,
safety experts, micro experts, to scrutinize your formula and
tell you that it is safe for use.
Senator Collins. Mr. Faber, a few years ago, I had an
adverse reaction to a personal care product, and I called the
1-800 number that was on the packaging. I was connected to
someone with some medical expertise.
He asked me whether it forced me to go to the emergency
room, and I said no. He said, well, did you have to go to the
doctor? I said no. He said, ``Well, then we will just send you
some coupons in the mail.''
[Laughter.]
That was his reaction. Sure enough, I got a bunch of
coupons in the mail.
Maybe my situation was unique or at least unusual, but
maybe there were thousands of incidences and reactions to this
product.
If there were, could you discuss the limits of FDA's
current authority to take action when they do find adverse
reactions to personal care products?
Mr. Faber. Thank you for the question, Senator.
As you have noted, right now, companies have no duty to
alert FDA if their consumers have been harmed by a product, and
then the FDA has very limited authority to respond. They cannot
suspend the production of a harmful product. They cannot order
a recall of a product.
If they determine under the 1938 law that the product is
adulterated, which is a very high bar, then they have to go to
the Justice Department in order to take action to protect
consumers. Of course, that is not the case for most other FDA-
regulated products.
Thankfully, your bill would address that problem in a
number of ways. In particular, once consumers like Eliana and
her mom have reported a serious adverse event like hair loss to
a company, then the company would have a duty to alert FDA
within 15 days.
For less serious adverse events, the company would annually
report those adverse events to FDA. That would allow FDA to
look for patterns that might help companies, large and small,
recognize that there might be a chemical or another ingredient
that it is causing less serious harm.
Senator Collins. See, I think that is why so many companies
actually welcome our bill, because they do not want to harm
consumers.
Particularly for smaller companies who do not have the
resources to investigate every ingredient, I think that FDA
ingredient review would be helpful.
Dr. Jonas, I have very little time left, so I am going to
be very quick. I was surprised at the difference between the
systems in Canada and in Europe, where there has been a review
process for decades.
Have you seen any problems with the systems used in Europe
and Canada that would explain why we have not moved in this
direction?
Ms. Jonas. Thank you for your question. The safety
assessment approaches in U.S. and Europe are very similar. Both
require that the companies are responsible for the safety of
the products, and that safety review and assessment must take
place before the products are put on the market. From a safety
perspective, we are very similar with Europe.
There are some places the FDA actually does go beyond,
which is the sunscreens we classify as a drug in the U.S., and
in Europe, they are a cosmetic.
There are other parts of the regulatory process, though,
where admittedly Europe is more advanced. They do require GMPs
under ISO 22716. They also require the reporting of serious
adverse events.
There are opportunities for the U.S. to harmonize with
other bodies, which would make it easier for businesses and
make the products better.
Senator Collins. Indeed, it is my understanding that 1,300
chemicals have been banned from personal care products in
Europe and the United States, which is quite a difference as
well.
Ms. Jonas. In Europe, they have banned more substances. But
when it comes to cosmetic ingredients, 90 percent of those
ingredients that they have banned are not cosmetic ingredients.
They are things like radioactive substances, jet fuel, LSD,
things you would not want in a cosmetic product.
Senator Collins. This is true.
Thank you, Mr. Chairman.
Senator Cassidy [presiding]. Thank you.
Senator Franken.
Statement of Senator Franken
Senator Franken. Thank you, Doctor.
As you can now probably tell, I personally use many beauty
products----
[Laughter.]
Senator Franken [continuing]. And would like to know if I
am harming myself.
As I imagine Senator Collins and Senator Feinstein did, I
read and was somewhat unnerved by the May 2015 New York Times
investigation into nail salons. As much as mainly we have been
talking about consumers here, that story is about manicurists
who had experienced miscarriages, children with developmental
delays, lung disease, and skin conditions. It was pretty
heartbreaking.
I guess what I will ask about are plans, let's go to Dr.
Bergfeld, the Cosmetic Ingredient Review panel has reviewed a
number of chemicals used in nail products, including toluene,
and listed them as safe in cosmetics up to a certain
percentage. However, the State of California has listed these
same chemicals as reproductive toxicants, and the European
Union has either banned or restricted their use.
Does the CIR take into account the long-term health risks
associated with chronic exposure to cosmetic products, for
example, when reviewing these products, the safety of nail
polish remover or other salon products? Does the panel consider
the safety of nail and hair salon workers who use products that
contain those harmful chemicals all day and over a long period
of time?
Dr. Bergfeld. Senator, if I could answer that briefly. We
look at the ingredient itself and its toxicological profile,
and we have felt that they were safe because of penetration,
inability for the nail product to penetrate the nails or the
skin surrounding it because of protection. It is not in our
purview to look at the salon.
Maybe Dr. Jonas can respond to that.
Ms. Jonas. When it comes to worker safety, that falls under
OSHA and NIOSH. They actually did do a review and establish
permissible levels for worker safety.
But we really enforce that salon owners need to be
licensed, and they need to provide those workers with the tools
and training to work safely.
Senator Franken. OK. Mr. Faber.
Mr. Faber. I would add that while OSHA does set permissible
levels for these chemicals like toluene, OSHA itself has said
they are badly out of date. They were set in the early 1970s.
There are some rules for safety training and equipment and
so on for salon workers, but there is very little oversight.
Further complicating this problem is that many salon
workers are independent contractors. They are not employees of
the salon, so they do not have all the protections that an
employee would have under labor law.
Senator Franken. OK. So you would consider the CIR
separates itself, it does not determine whether long-term
exposure to something constitutes a hazard?
Dr. Bergfeld. If you remove the nail product, I could
answer that, generally, yes, we do. We do report the
epidemiology and the case reports. We do look at long-time
human exposure as reported in the literature and by the
industry.
We have in our discussion of each ingredient these kinds of
issues, with the exception that we are dealing with the
ingredient safety itself, the chemical safety of that
ingredient, and not the whole product. That falls out of our
purview of review, only to add it to our discussion of concern.
But we have no action on how it is used, say in the salon
for the nail products.
Mr. Faber. I would add one challenge with any self-
regulatory program for any industry is characterizing those
repeat exposures over many years. Agencies are in a much better
position to collect the data necessary to know precisely how
many times a consumer or a worker would be exposed to a
particular chemical and ultimately be in a better position to
figure out what is the threshold that you should not cross if
you are trying to avoid certain health outcomes.
While certainly it is helpful for self-regulatory programs
to supplement what agencies like FDA, EPA, CPSC can do, they
are not a substitute because they simply do not have the
ability to access the same sorts of data that a regulator like
EPA or FDA would have access to.
Dr. Bergfeld. Could I respond to that? In our reviews, we
look at the margin of safety, and we do account for some of
that exposure in the margin of safety, which is usually 1,000
fold. We do make sure that there is a large margin of safety
for exposure, and realizing that the cosmetic ingredient is one
small chemical within a product that may have 20 ingredients,
all of which affect that one ingredient as well.
Senator Franken. I think that we should be also dealing
with how the people who are exposed to this constantly over a
long period of time are affected by these products.
I do not know about anybody else, did anybody else read
that series?
Mr. Faber. Yes, sir.
Senator Franken. Were you disturbed by it?
Mr. Faber. It is very troubling.
Dr. Bergfeld. Yes, of course.
Senator Franken. OK, thank you.
Statement of Senator Cassidy
Senator Cassidy. My turn.
Ms. Dandurand, I was actually very struck by yours because
I often think of government regulations as being a hurdle put
in there by incumbent industry to prevent upstarts like you
from gaining traction, not that they are being malicious, but
that is just how it works.
But you are telling me that this national standard actually
makes it easier for a startup, if you will, to enter the
business and go nationwide, just to confirm what you said.
Ms. Dandurand. Yes, absolutely.
Senator Cassidy. OK. That is very helpful.
Mr. Faber, a lot of what is involved here is the supply
chain, right? I am a physician. You may or may not be familiar
with the fact that China a few years ago was using pigs to
develop some ingredients for heparin. It turns out it created a
lot of problems for people on dialysis. They bled out.
I guess the question is--and this may be in the
legislation. I just do not comprehend it. Once we have this
kind of process in place and a product is ruled safe, but then
there is some adulteration that occurs in the supply chain from
a foreign country, for example, how does this legislation
address that? Will the maker--Ms. Dandurand with Jack Black--be
responsible for something which has been adulterated through no
fault of theirs, perhaps even previously approved, but now
contaminated with a drug which is known to be unsafe?
Mr. Faber. That is a terrific question. Thank you, Senator.
I am sure that manufacturers like Jack Black are doing
everything they can on their own to police their own supply
chain to ensure their suppliers are adopting----
Senator Cassidy. I brought up the pharmaceutical because
they are under the microscope and it still happened to them.
Mr. Faber. I think they are two very quick answers to your
question.
One is, as Ms. Jonas said, having the U.S. join other
nations in requiring good manufacturing practices and having
other countries adopt those standards so that these ingredients
are being produced in a safe and clean environment. That is one
step.
The second step, and I wish Senator Murray was with us to
talk about this, is to perhaps look at what Congress did in the
Food Safety Modernization Act where we asked, ultimately, the
formulator of the final product to ensure that their supply
chains had systems in place to ensure that those ingredients
were----
Senator Cassidy. OK, let me go back to Jack Black being a
startup. If somebody is buying chemicals from Vietnam--it
happens regularly--she may not be capable of flying over to Ho
Chi Minh City to make sure that it is continually processed, or
even if she does, to ensure that it continues to be.
Is the onus falling upon Jack Black? Will she be held
liable if there is some problem with the supply chain that is
kind of beyond her ability to know, just like that heparin
issue way back when?
Mr. Faber. Ultimately, even the current law, as weak as it
is, requires the maker of any cosmetic or personal care
product, including Jack Black, to make sure their product is
not adulterated, not contaminated. Responsible companies are
already taking steps to ensure that there is no contamination
in their supply chains.
I think it is also important to note that in all of these
industries, whether it is the food industry, drugs, cosmetics,
devices, there are third parties who also help companies police
their supply chains and ensure that those ingredients are being
made in a safe and clean environment.
Senator Cassidy. So Jack Black, if you will, could contract
with a third party to make sure that whatever is being produced
in Vietnam is actually what she has contracted for?
Ms. Dandurand. Yes, it all comes down to the manufacturer
that you use. Small companies usually outsource their
manufacturing, so it is vital that you have a lot of visibility
to that manufacturer and their raw material purchasing
procedures and QA, things like that.
And yes, we have audits of our manufacturers.
Senator Cassidy. OK. Again, I am very sensitive and very
kind of admiring of you all to be able to come from nothing to
be quite something. But this is something that someone else
could do as well without an undue burden, that third party to
make sure, kind of periodically audit, to make sure that the
input for your product would be safe.
Ms. Dandurand. If our manufacturer changes the raw material
supplier they are buying from, they have to notify us and we
have to prove that.
Senator Cassidy. Got you.
Ms. Dandurand. There are checks and balances.
Senator Cassidy. You have a contract manufacturing outfit
and you give them the recipe, so to speak, your IP, and then
they produce it and they ensure you that the product is safe.
Ms. Dandurand. That the raw material ingredients are to
specification, that they passed the quality assurance, and they
do not change suppliers without notifying us and getting our
approval.
Senator Cassidy. Got you. A couple other things.
Dr. Jonas, you referenced the Cosmetic Ingredient Review
regularly reviews materials for safety in human use, and you
have mentioned some have been found unsafe. How long did it
take between the finding of lack of safety, if you will, to
change the commercial use of the ingredients?
Ms. Jonas. When an ingredient is determined by CIR to be
unsafe, that is reported to the FDA and that is their
responsibility to either take action or not take action.
Senator Cassidy. Do you have a sense how quickly this
occurs? Is it like 2 weeks or is it like an ``oh my gosh, it
has been 4 years and they still have not issued a ruling'' sort
of thing?
Ms. Jonas. We can notify right away. At that point, it is
their responsibility.
Senator Cassidy. I guess I am asking how quickly they
respond to that responsibility.
Dr. Bergfeld. I can respond briefly to it. We have had the
ability over the last many years to reflect on the unsafe use
and have monitored it and seen it go down and decline markedly.
Because we have called it unsafe, it seems to have an impact.
Senator Cassidy. OK. I think I just read a quote by Justice
Brandeis who spoke about publicity being an antiseptic or
something, something driving out bad behavior. It does not
always happen, but sometimes.
OK, I think that is it. Thank you all for being here, by
the way.
I have to admit, I had to, as you were testifying, look up
on my phone what a Brazilian blowout is.
[Laughter.]
Senator Cassidy. At the risk of being earthy, I am a
gastroenterologist, and I had different images in my mind.
[Laughter.]
Senator Cassidy. That is it.
The hearing record will remain open for 10 days. Members
may submit additional information for the record within that
time, if they wish.
Thank you for being here today. The committee stands
adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Prepared Statement of Senator Baldwin
Cosmetics are among the least regulated consumer products
on the market. Yet, research suggests that chemicals contained
in many of the personal care products we use every day are
linked to cancer, learning disabilities, and other health
problems. I believe it is critical to modernize the Food and
Drug Administration's (FDA) oversight of cosmetics to protect
the health of American citizens and our environment.
During my time in the House of Representatives, I
introduced the Safe Cosmetics Act with my colleague
Representative Janice Schakowsky. This proposal would close a
major gap in Federal oversight by requiring company
registration, comprehensive ingredient labeling and safety
testing, and disclosure of health hazards for workers. It would
also provide FDA with more resources to protect consumers from
harmful products.
I am encouraged that my colleagues in the Senate, Senators
Dianne Feinstein and Susan Collins, have introduced bipartisan
legislation on this important issue and that this committee has
taken an interest in improving the safety of cosmetics and
personal care products. It is important that we take this
opportunity to enact meaningful changes for consumers, workers
and businesses, and I look forward to further review of
legislative proposals in this space.
Prepared Statement of Anne-Marie Faiola
Chairman Alexander, Senator Murray, and members of the committee,
thank you for the opportunity to submit testimony as the committee
explores the important issue of cosmetic safety and consumer
protection.
My name is Anne-Marie Faiola and I am the president of the
Coalition of Handcrafted Entrepreneurs. Our coalition works to
represent the hundreds of thousands of mostly small, women-owned
businesses and hobbyists in the handcrafted personal care products
industry.
Across the Nation, at farmers markets and on the shelves of your
local natural foods store, our members are offering consumers a safe,
artisan product while also supporting their families with a second or
sometimes only source of income. Like me, most people entering this
industry started as hobbyists--many of them looking for an all-natural
alternative to traditional cosmetic products for their families--but
soon came to realize that they could transform their passion into a
livelihood.
I have been involved in the handcrafted personal care products
industry for 20 years. I founded my own company, Bramble Berry, Inc.,
in my living room and today I employ approximately 62 people in
Bellingham, WA, from where I ship the raw ingredients and supplies used
for making soap and cosmetics to all 50 States.
Our coalition shares the priority of consumer advocates to ensure
the safety of products we ingest and put on our bodies, including
handcrafted beauty products. We favor reforms that enhance consumer
safety and transparency, more specifically: requiring reporting of
adverse events; giving the FDA recall authority; and improving the
clarity and consistency of product labeling. These reforms would
provide important improvements in the marketplace.
But we are concerned with the approach some consumer advocates and
those in the industry have rallied around because it would place undue
burdens on small businesses by requiring ingredient reporting and
testing, along with other forms of product safety substantiation.
Holding small businesses to the same standard of recordkeeping,
ingredient filing, and testing as large, multi-national corporations is
simply not fair and very likely would cause a significant negative
disruption in the handcrafted industry. In our view, consumer choice is
enhanced by the presence of handcrafted products in the personal care
products industry. In many respects, this one-size-fits-all approach
seems to be a solution in search of a problem that will only result in
less consumer choice by forcing thousands of small businesses out of
the marketplace.
It is important to understand the supply chain for the handcrafted
personal care product industry. The majority of businesses operating in
this space purchase their ingredients from suppliers, who aggregate
ingredients and distribute them on a per order basis. These ingredients
include: (1) ``fixed oils'' like avocado oil, cocoa butter, palm oil,
shea butter, and olive oil; (2) fragrance oils, whether a natural
essential oil or synthetic blend; and (3) colorants, including oxides
and pigments, mica, FD&C colorants, as well as herbs and clays.
Many of these ingredients fall into the class of ``Generally
Recognized As Safe'' for food-grade products, or ``GRAS,'' while
others, like essential oils and cosmetic chemicals, and some fragrances
and colorants, already have substantial safety testing and use
protocols associated with them. These ingredients come with an OSHA
Safety Data Sheets (SDSs) [formerly known as Material Safety Data
Sheets or MSDSs], safe usage instructions, Certificate of Analysis, and
an EU Allergen Report.
We believe that any changes to the existing regulatory structure
should recognize that a majority of ingredients used today by the
handcrafted industry are substantially similar to off-the-shelf
products available at your local grocery store, and even for those not
readily available, many have already undergone a high degree of
research and analysis associated with safe use and handling.
It is worth nothing that the FDA already has and regularly
exercises its authority to inspect and enforce existing regulatory
controls, including those regarding product labeling, and that many of
these actions involve small businesses.
The other major concern we have regarding legislation that has been
or is soon-to-be introduced is with the exemption levels included for
small businesses.
First, with respect to cosmetics, legislation generally has
proposed an exemption level that is too low. It would be extremely
difficult--if not impossible--for a small business making $100,000 per
year to comply with all of the new regulations and costs associated
with compliance and still have a viable business. Moreover, such a low
exemption level is inconsistent with more recent legislative efforts at
both the Federal- and State-level with respect to food production and
also cosmetics.
For example, the 2005 ``California Safe Cosmetics Act'' has been
hailed by the Campaign for Safe Cosmetics as ``ensure[ing] consumers
have access to safer products and more information about the safety of
the products they buy.'' The California law provided for a small
business exemption level of $1 million.
Our second concern is that these bills represent a shift by
Congress away from deferring a decision about specific exemption levels
to rulemaking and instead arbitrarily setting an exemption level in
statute. Such an approach significantly limits public comment, input
from the industry itself and the Small Business Administration, which
has a responsibility to ensure that new regulations do not unduly
burden small businesses. We are concerned that this approach removes an
important element of due process, or at the very least, a more
transparent process that takes into account the true cost of
compliance.
Our last concern with the exemption level is associated with fees.
Several of the bills introduced have a fee structure that would impose
costs on small businesses that are disproportionate to their share of
the marketplace. We think this is unfair and discriminatory.
Again, we in the handcrafted industry appreciate the opportunity to
participate in this important discussion. Ensuring consumer safety and
transparency in the marketplace is the hallmark of the handcrafted
industry. We hope the committee will consider our concerns and take
appropriate measures to ensure the continued viability of this small,
but important, component to the Nation's personal care products
marketplace.
[The New York Times, August 15, 2016]
Their Hair Fell Out. Should the F.D.A. Have the Power to Act?
(by Eric Lipton and Rachel Abrams)
Eliana Lawrence, 11, went bald three weeks after she started using
a Wen cleansing conditioner in late 2014, her mother said. Last week,
Eliana's hair still showed some bald spots.--Credit: Nick Cote for the
New York Times
Washington.--When the Los Angeles hairstylist Chaz Dean pitched his
almond mint and lavender-scented hair care products--endorsed by
celebrities like Brooke Shields and Alyssa Milano--he sold millions.
But his formula got an unexpected result: itching, rashes, even hair
loss in large clumps, in both adults and children.
More than 21,000 complaints have been lodged against his Wen Hair
Care, and Mr. Dean, the blue-eyed, golden-haired stylist to the stars,
has found himself at the center of a fierce debate over the
government's power to ensure the safety of a cosmetics industry with
about $50 billion in annual sales.
The Santa Monica, Calif.-based national distributor of Mr. Dean's
hair care line is part of a beauty care trade association that has been
aggressively lobbying Congress to block the passage of tough new
legislation that would give the Food and Drug Administration the
authority to test ingredients used in cosmetics and issue mandatory
recalls for products found to be unsafe.
The fight has pitted smaller independent players against the giants
of the beauty products industry, which back the proposed regulations,
seeing them as an avenue toward regaining public trust, and have the
size and muscle to comply with them.
Each side has its champions in Congress: Senators Dianne Feinstein,
Democrat of California, and Susan Collins, Republican of Maine, for the
larger companies, and Representative Pete Sessions, Republican of
Texas, coming to the aid of his home-State company, Mary Kay, which
joined the Independent Cosmetic Manufacturers and Distributors to fight
the Feinstein-Collins legislation. Mr. Sessions has introduced
competing legislation backed and largely drafted by Mary Kay and the
independent companies.
``If you are in business and are not involved in politics, then
politics will run your business,'' explained a presentation prepared by
Mary Kay last summer for sales representatives and obtained by The New
York Times.
The face-off comes amid growing consumer concern about the safety
of beauty care products and follows a string of other scares, including
the discovery of hair products and skin creams containing hazardous
ingredients such as formaldehyde and mercury.
Chaz Dean at a holiday party he hosted in Los Angeles in December.
More than 21,000 complaints have been lodged against his Wen hair
products.--Credit: Araya Diaz/Getty Images
``People don't realize there is effectively no regulation of
cosmetics,'' said Representative Frank Pallone Jr., Democrat of New
Jersey. He, along with Ms. Feinstein and Ms. Collins, has pushed to
strengthen a 1938 law that was passed to regulate the pharmaceutical
industry but contained two pages that addressed cosmetics, leaving it
essentially unregulated.
Joe Hixson, a spokesman for Guthy-Renker, the distributor of Wen,
said the company has ``evidence and studies that we believe demonstrate
Wen is safe and does not cause hair loss.''
Mr. Dean's hair care product does not actually lather. Instead, Mr.
Dean promotes it as ``a revolutionary way to cleanse'' the hair without
the use of traditional detergents or sulfates, chemicals some consumers
have objected to.
``In addition to it sounding like `Zen,' the system is a completely
reverse way of looking at cleansing the hair,'' the product's website
boasts. ``Thus, `Wen' is `new' spelled backward.'' The company also
sells what it calls ``unique formulations gentle for pediatric use.''
Miriam Lawrence of Denver said she used Wen's Sweet Almond Mint
Cleansing Conditioner on the hair of her daughter, Eliana, then 9,
about three times in late 2014. Within days, her daughter's brush was
full of hair. Three weeks later, Eliana was bald.
``It changed our life in just a couple shampoos. It's ridiculous,''
said Ms. Lawrence, whose daughter has grown back most of her hair and
eyebrows. ``It was marketed to be extra gentle, no harsh chemicals.''
Mr. Pallone, in a letter to the F.D.A. and Guthy-Renker, has
pressed for answers about the Wen case. In an interview he cited it as
an example of why current law is failing and more rigorous regulation
is needed.
For legal reasons, the government's hands are tied.
That is in part because unlike pharmaceutical companies, cosmetic
companies are not required to notify the government of ``adverse
reaction'' reports--even if someone dies.
Wen's Sweet Almond Mint Cleansing Conditioner, which Miriam
Lawrence used on the hair of her daughter, Eliana.--Credit: Nick Cote
for The New York Times
The F.D.A. instead has had to depend on consumers stepping forward,
and as of July 7, only 127 reports had been filed to the agency
detailing problems with the Wen hair care line. But inspectors sent to
the company's facilities dating back to 2011 learned that complaints to
the company and distributor total more than 21,000, the agency said
last month.
``You know how the stars were saying it was so good and it made
your hair more manageable, more shinier?'' said Bonnie Iqbal, 55, of
Albany, who last year was among those who sued the company after her
hair began falling out. ``So I figured, you know, I'd try it.''
Patricia J. Zettler, a health law and policy expert at Georgia
State University and a former F.D.A. lawyer, said that under existing
law, the agency could take action against the company only if it could
prove a product had been mislabeled or contaminated. If the product
turns out to be dangerous but legal, the government has no recourse.
``The bottom line is, if the company has not violated the law,
there isn't really anything F.D.A. can do,'' Ms. Zettler said.
Even in the absence of Federal action, Guthy-Renker, in a
``business decision,'' agreed in late June to a $26.25 million legal
settlement--still not approved by a Federal court judge--that would
repay up to $25 to every person who has bought a bottle since Wen
products were introduced and as much as $20,000 to individuals claiming
hair loss or other injury. Yet the product is still being sold, and the
F.D.A., other than issuing a notice saying it is looking at the matter,
has taken no action.
The Feinstein-Collins bill is intended to eliminate such
stalemates. It would, for the first time, require that cosmetics
manufacturers report ``serious adverse'' reactions to their products to
the F.D.A. as they come in, as well as create an annual report of all
``adverse events.'' It would also give the agency the power to order
companies to recall products found to be dangerous.
The bill would collect about $20 million in fees annually from
beauty care companies to help cover the cost of confirming the safety
of about five ingredients each year that are suspected of causing
problems, such as lead acetate, a color additive in hair dyes, and
quaternium-15, a preservative used in certain shampoo and cosmetics.
The legislation has won the endorsement of heavyweights including
Este Lauder, whose brands include Clinique, Origins, MAC, La Mer, and
Bobbi Brown; Johnson & Johnson, maker of Neutrogena and Aveeno; and
Procter & Gamble, whose brands include Pantene, Head & Shoulders,
Herbal Essences and Olay. Industry officials said they decided to
embrace the legislation after becoming increasingly concerned that a
decline in consumer confidence could hurt their sales.
Photographs showed the progress of Eliana's hair loss in late
2014.--Credit: Nick Cote for The New York Times
``The Feinstein-Collins bill is supported by a vast and diverse
group of people and groups who all want the same thing--cosmetic
regulations that best serve the public health and give consumers
confidence in the products and ingredients they choose for their
families,'' Darrel Jodrey, a top Federal lobbyist at Johnson & Johnson,
said in a statement.
Major national environmental, consumer and health nonprofits, such
as the American Cancer Society, the Environmental Working Group and the
Good Housekeeping Institute, have also backed the plan.
But even before Ms. Feinstein formally introduced her legislation
in April 2015, the Independent Cosmetic Manufacturers and Distributors,
in which Guthy-Renker has been a dues-paying member for over a decade,
moved to defeat it, internal documents obtained by The Times show.
During a March 2015 strategy session in the New York law offices of
a trade association legal adviser, Locke Lord, industry executives were
briefed by their lobbying team, who explained that it had already
approached the office of Representative Fred Upton of Michigan, the
chairman of the House Energy and Commerce Committee, with jurisdiction
over the F.D.A.
Michael Lunceford, a senior vice president at Mary Kay overseeing
the company's lobbying and public affairs divisions, had done
groundwork through the Direct Selling Association, where he is on the
board, to help Mr. Upton's 2012 re-election effort. The organization
bought billboard, radio and newspaper ads ``to gain the attention of
the candidate in order to cultivate a champion for the direct selling
industry,'' according to an industry newsletter.
Guthy-Renker hired its own well-connected Washington help: William
R. Nordwind, a lawyer and lobbyist who spent a dozen years working as a
staff member and campaign aide to Mr. Upton. Mr. Hixson, the Guthy-
Renker spokesman, said the company had not publicly taken a position on
the Feinstein-Collins bill, although it financially supported the
independent cosmetics industry association. Mr. Nordwind's team, from
the Venable lobbying firm, has contacted Capitol Hill on behalf of the
company, Mr. Hixson said.
``They have got a bad story out there right now,'' Robert Harmala,
a former House aide who lobbies for the Independent Cosmetic
Manufacturers and Distributors, said regarding Guthy-Renker and its Wen
product line. ``They don't want to be the face of the industry for
having done this.''
Mary Kay claims credit for persuading Mr. Sessions, whose Dallas-
area district is near its headquarters, to sponsor alternative
legislation. Mr. Sessions's proposal still would require beauty care
companies to notify the F.D.A. of ``serious cosmetic adverse events,''
but it would not grant the agency the power to order a recall or
collect industry fees to pay for new programs, such as the safety
evaluation of cosmetics ingredients. Most important for direct sellers
like Guthy-Renker, Mary Kay and other members of the independent
cosmetics group, it would broadly and retroactively pre-empt any
tougher state laws.
Bonnie Iqbal, 55, of Albany, used Wen's products and sued after her
hair started falling out.--Credit: Nathaniel Brooks for The New York
Times
``We can't just be out there saying, `No, we don't like Feinstein's
bill,' '' Mr. Harmala said in an interview.
Mr. Sessions, after introducing the legislation, became a favorite
of the cosmetics industry, campaign finance records show, emerging as
the top recipient in Congress of donations from Mary Kay employees, and
taking donations from at least 10 other industry executives, including
Pam Busiek, the president of the Independent Cosmetic Manufacturers and
Distributors. Executives at Guthy-Renker were not among the donors.
More industry donations were sent to Representatives Eddie Bernice
Johnson, Democrat of Texas, and Bill Flores, Republican of Texas, the
only other two House lawmakers to help sponsor the bill.
Crayton W. Webb, a spokesman for Mary Kay, said the company was
committed to helping pass a law that increased the Federal Government's
oversight of the industry, but opposed Ms. Feinstein's bill because
``it falls short in providing one clear national and uniform safety
standard.''
Ms. Busiek added, ``We want something that is not overreaching.''
Mr. Dean declined to comment.
The F.D.A. would not comment on the proposals. So far, the agency
said, it has found no evidence of contamination or misbranding in Wen
products, the only two product flaws it can use to press a company to
agree to a voluntary recall. The agency has requested the results of
safety tests and other manufacturing data, but it cannot compel the
company to release any information.
``That's why it is so critical that we get information directly
from consumers and their health care providers,'' said Susan Mayne, the
director of the F.D.A.'s Center for Food Safety and Applied Nutrition.
For consumers dealing with thinning hair, itchy scalps and other
problems, the additional responsibility of bringing their case to the
government can be a tall order--and certainly a confusing one. The
government should be helping them, they say.
``I think it would be great for the F.D.A. to step in a little bit
more,'' said Melanie Guitzkow, a 20-year-old student, who said her hair
began to fall out when she used Wen in high school. ``Some things,
like, shouldn't be on the market because they're damaging.''
______
Response by the Department of Health & Human Services,
Food and Drug Administration, to Questions of Senator Alexander
Department of Health & Human Services,
Food and Drug Administration,
Silver Spring, MD 20993,
October 17, 2016.
Hon. Lamar Alexander, Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Mr. Chairman: Thank you for your letter dated September 16,
2016, in which you requested information about the Food and Drug
Administration's (FDA or the Agency) current regulatory authority over
cosmetics and personal care products. We appreciate the opportunity to
respond.
During the past several years, Americans have seen a dramatic
increase in the numbers and types of cosmetic products on the market.
Billions of personal care products, which include primarily cosmetics
but also some over-the-counter drugs and some products regulated by the
Consumer Product Safety Commission, are sold annually in the United
States. Cosmetic products and ingredients are also entering the United
States from a growing number of countries, most of which have
regulatory systems and standards that are different from those of the
United States. We expect this upward trend in imported cosmetics and
cosmetic ingredients to continue.
FDA's regulatory authority for cosmetics under the Federal Food,
Drug & Cosmetic (FD&C) Act has not been updated (except for color
additives) since 1938. Under current law, FDA has much less legal
authority to protect consumers from unsafe cosmetics than it does for
other products the Agency regulates. Even though Congress has updated
FDA' s enforcement authorities over other products, it has not done so
for cosmetics. As a result, FDA's oversight of cosmetics is limited.
The Administration recognizes the need to strengthen FDA's regulatory
program for cosmetics, and the President's budget in the past few years
has requested authority to require cosmetic firms to register their
establishments and products with FDA and to pay a user fee. Additional
measures necessary for an effective cosmetic safety program are
discussed in Question 1 below.
We have restated your questions below, followed by our responses.
We look forward to working with you on these issues.
______
Question 1a. Please describe the statutory and regulatory
authorities that FDA currently uses to help ensure the safety of
ingredients found in cosmetics and personal care products?
Answer 1a. The FD&C Act defines cosmetics as ``articles intended to
be rubbed, poured, sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body . . . for cleansing, beautifying,
promoting attractiveness, or altering the appearance'' (Sec. 20l(i) [21
U.S.C. 32l(i)]). Among the products included in this definition are
skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and
facial makeup, cleansing shampoos, permanent waves, hair colors,
deodorants, and substances intended for use as a component of a
cosmetic product, however, a product is intended for a therapeutic use,
such as treating or preventing disease, or to affect the structure or
function of the body, it is a drug (Sec. 20l(g) [21 U.S.C. 321(g)]), or
in some cases a medical device (Sec. 20l(h) [21 U.S.C. 32l(h)]), even
if it affects the appearance. For example, sunscreens are regulated as
drugs. Products such as dandruff shampoos, fluoride toothpastes, and
deodorants that are also anti-perspirants, are regulated as both
cosmetics and drugs.
Cosmetic products and ingredients, other than color additives, are
not required to have FDA approval before they go on the market.
Cosmetic manufacturers are not required to register with FDA or list
their products. FDA encourages cosmetic firms to report product
formulations through the Agency's Voluntary Cosmetic Registration
Program (VCRP).
Cosmetic firms are responsible for substantiating the safety of
their products and ingredients before marketing, although they are not
required to submit safety substantiation data to FDA. In general,
except for color additives and those ingredients which are prohibited
or restricted from use in cosmetics by regulation, a manufacturer may
use any ingredient in a cosmetic, provided the ingredient does not
adulterate the finished cosmetic and the finished cosmetic is properly
labeled.
Current regulations specify the labeling requirements for
cosmetics. These requirements include the name and place of business of
the manufacturer, packer or distributor; material facts about the
product; directions for safe use (if needed); and a list of
ingredients.
In the case of imported products, those products that appear not to
comply with U.S. law may be refused entry into this country. In
addition, FDA may place a company or product on an Import Alert, which
advises import inspectors that FDA has evidence of past violations or
other information about firms and products indicating that the product
may be in violation of FDA requirements.
FDA may take post-market actions against cosmetics that are shown
to be adulterated (for example, if a cosmetic contains a poisonous
ingredient that makes the product harmful when used according to
directions on the label or in the customary way) or misbranded (for
example, if its labeling is false or misleading). FDA, through the
Department of Justice (DOJ) can pursue seizure of adulterated or
misbranded products and injunctions against firms or individuals that
violate the law. DOJ also can take criminal action on FDA's behalf.
Question 1b. Which of these authorities, if any, does FDA believe
should be strengthened? To what extent would a change in statute be
required to accomplish such strengthening?
Question 1c. Please identify any additional specific post-market
authorities regarding cosmetics and personal care products that FDA
believes should be considered to protect the public health.
Answer 1b and 1c. FDA engaged in a series of discussions with
industry in 2013 about how to modernize the cosmetics regulatory
framework. Topics discussed at the time included registration and
listing for manufacturers and their products, user fees, strengthening
authority to assure substantiation of safety, mandatory adverse event
reporting, mandatory recall authority, records review by FDA, and
ingredient and non-functional constituent review under a ``reasonable
certainty of no harm'' safety standard. Most of these elements are
typical of a regulatory framework for many other FDA-regulated
products, and could not be implemented without new statutory authority.
Unlike other products regulated by FDA, cosmetics manufacturers are
not required to register with FDA or list their products. This means
that FDA does not have complete and reliable information about the
universe of companies that are marketing cosmetics to American
consumers or what is in their cosmetic products. Although FDA
encourages cosmetic firms to report product formulations through VCRP,
companies are not legally required to tell FDA about their products, or
the location of their manufacturing facilities. As with any voluntary
system, we do not have full participation, which limits our knowledge
of who is selling cosmetic products in the United States and what
products are being sold. Mandatory registration and reporting, as
requested in the President's budget, would allow us to know what
cosmetics are on the market, where they are manufactured, and what
ingredients are present in them.
In addition, user fees, also requested in the President's budget,
would be necessary to carry out registration, as well as provide
support for the cosmetics program. For example, because resources are
limited, at most 100 cosmetics firms are inspected each year. The user
fee requested in the President's budget would be used, in part, to
refine inspection and sampling of domestic and imported products and
apply risk-based approaches to post-market monitoring of domestic and
imported products and other enforcement activities.
Cosmetic firms are not required to submit to the Agency their
safety studies for cosmetic products or ingredients. FDA can request
the safety studies as part of an investigation, but the firm decides
whether they wish to share the requested information with FDA.
Cosmetic manufacturers are not required to submit adverse event
reports to FDA. We estimate that the adverse event reports we receive
represent only a fraction of the actual number of cosmetic-related
problems. Further, we receive few reports from health care providers,
and the reports received from consumers typically lack critical
information to help make medical assessments of the problems. The lack
of reliable information makes it difficult to assess the true nature of
problems with cosmetics and can delay efforts to respond to the
complaints. For example, while we had received around 100 adverse event
reports about WEN cleansing conditioner hair products, we learned upon
inspection that the manufacturer and distributor had received more than
21,000 complaints, including irritation, hair breakage, hair loss, and
baldness. The absence of a requirement to submit adverse event reports
has significantly delayed our efforts to ascertain and respond to the
complaints because we did not learn of them in a timely way.
FDA can ask manufacturers to voluntarily recall unsafe products. If
manufacturers do not remove dangerous products from the market once a
safety concern emerges, FDA can issue a press statement to alert
consumers, but our only means of legal enforcement action to protect
consumers is to bring a court case. As noted above, FDA, through the
Department of Justice (DOJ) can pursue seizure of adulterated or
misbranded products and injunctions against firms or individuals who
violate the law. DOJ also can take criminal action on FDA's behalf.
FDA can inspect manufacturing facilities to determine if cosmetics
are manufactured under sanitary conditions, but there are no Good
Manufacturing Practices requirements for cosmetics. Unlike other
product categories, FDA does not have authority to inspect records for
cosmetics, such as manufacturing records, consumer complaints, and
adverse event reports.
Question 2. How does FDA currently prioritize inspections of
cosmetic manufacturing or distribution facilities? As part of this
response, please provide the number of inspections FDA carries out
annually, the basis for such inspections, and the number of inspections
that have resulted in an enforcement action or warning letter.
Answer 2. Inspections are prioritized in two ways. First, as part
of the fiscal year work plan, district offices are instructed by the
Office of Cosmetics and Colors (OCAC) to select establishments based on
high-risk products. Currently, high-risk products are defined as eye-
area cosmetics, baby wipes, healthcare related lotions and creams,
tattoo ink, non-alcohol mouthwash and seasonal face paints.
Approximately 75 to 100 inspections of cosmetic establishments are
performed annually this way.
In fiscal year 2015 and fiscal year 2016, eight letters (Warning,
Untitled) have been issued as a result of risk-based inspections, as
shown in the following table:
------------------------------------------------------------------------
Number of
Fiscal year risk-based Number of
inspections letters
------------------------------------------------------------------------
FY 2015....................................... 88 4
FY 2016....................................... 110 4
------------------------------------------------------------------------
Second, OCAC issues a list of approximately 25 firms to receive for
cause inspections based on prior compliance activity. This includes
manufacturers of cosmetics that have been the subject of a warning
letter for labeling violations (usually drug claims) or microbiological
contamination, firms that manufacture products that have been recalled,
and firms that manufacture products frequently associated with adverse
events reported through MedWatch.
In fiscal year 2015 and fiscal year 2016, five letters (Warning,
Untitled) have been issued as a result of OCAC directed inspections, as
shown in the following table:
------------------------------------------------------------------------
Number of
Fiscal year directed Number of
inspections letters
------------------------------------------------------------------------
FY 2015......................................... 20 4
FY 2016......................................... 23 1
------------------------------------------------------------------------
Question 3. Within the last 5 years, how many cosmetic products has
FDA found to be adulterated or misbranded? Of these products, what
actions did FDA take to ensure the company or manufacturer corrected
the violation and/or became compliant with FDCA or FPLA? Please provide
details regarding completed followup actions.
Answer 3. Within the last 5 years, FDA has found 1,681 cosmetic
products to be adulterated, misbranded, or marketed as unapproved new
drugs, based on data from alerts and issuance of warning letters. These
numbers represent product types, not the total number of individual
items in market circulation. The detailed data are provided below.
Once FDA has identified a violation and notified the company, the
company has a specified amount of time (in the case of a warning
letter, 15 business days) to bring the product into compliance. FDA
then carries out a followup investigation to ensure that the violation
has been corrected. These followup actions include, for example,
sampling of products and reviewing the labeling (including company
websites).
The following are investigations (cases) linked with adulteration
charges under section 601 [21 U.S.C. 361) of the FD&C Act and for which
action was taken:
2016: 82 cases
2015: 76 cases
2014: 62 cases
2013: 81 cases
2012: 83 cases
Total: 384 cases, involving an estimated 1,152 products.
The following are cases in which products were found misbranded
under section 602 [21 U.S.C. 362] of the FD&C Act and for which action
was taken:
2016: 27 cases
2015: 18 cases
2014: 25 cases
2013: 25 cases
2012: 20 cases
Total: 115 cases, involving an estimated 345 products.
The number of products charged in each case can vary from one to
several products. The average number of products evaluated per case is
three products.
In addition, OCAC evaluates products to determine whether they are
drugs under the FD&C Act. A product intended to diagnose, mitigate,
treat, or prevent disease, or to affect the structure or function of
the body is classified as a drug and if such a product is not generally
recognized by qualified experts as safe and effective when used as
labeled, it is a ``new drug.'' Below is the number of cases in which
products were charged as unapproved new drugs under the FD&C Act, Sec.
505(a) [21 U.S.C. 355(a)]. Of these cases, 46 resulted in warning
letters between 2012 and 2016:
2016: 25 warning letters
2015: 9 warning letters
2014: 3 warning letters
2013: 0 warning letters
2012: 9 warning letters
Total: 46 warning letters (each warning letter citing an average of
about 4 products, for an estimated total of 184 products).
We note that in late 2015 and throughout 2016, we began a project
of reviewing product labels and websites for drug claims related to
anti-aging, which resulted in an increase in warning letters in 2016.
Question 4a. We understand that FDA's Adverse Event Reporting
system for cosmetics is a voluntary reporting system maintained by the
Center for Food Safety and Applied Nutrition (CFSAN) that captures data
on adverse events and product complaints reported about cosmetics as
well as food and dietary supplements.
Please describe the process by which adverse events relating to
cosmetics are (1) reported to FDA, and (2) received and analyzed within
the agency. Who within CFSAN is responsible for analyzing cosmetic-
related adverse event reports?
Answer 4a. Consumers, health professionals, and members of the
cosmetics industry can voluntarily report a complaint or adverse event
in a number of ways: by calling an FDA Consumer Complaint Coordinator
if they wish to speak directly with a person, completing an electronic
MedWatch form online, or by completing a paper MedWatch form that can
be mailed to FDA. More specifically, adverse event reports relating to
cosmetics are received by the CFSAN Adverse Events Reporting System
(CAERS) through multiple sources: MedWatch, email, phone, fax, Field
Accomplishment Computerized Tracking System (FACTS) through FDA's
consumer complaint coordinators, or through the Center for Drug
Evaluation and Research's Central Triaging Unit.
From the CAERS system, individual adverse event reports relating to
cosmetics are forwarded to and analyzed by expert reviewers in OCAC,
which has primary responsibility for analyzing cosmetic-related adverse
event reports and recommending followup responses. In addition,
epidemiologists, statisticians, and signal managers within CFSAN's
Office of Analytics and Outreach may analyze aggregate data from CAERS
to identify trends or signals.
Question 4b. How many reports has CFSAN's Adverse Events Reporting
System (CAERS) received related to cosmetic products for each of the
last 5 years? How does this number compare to other product categories
within CFSAN and in other FDA centers?
Answer 4b. In each of the last 5 years. FDA received the following
number of cosmetics-related adverse event reports:
2011: 358 reports
2012: 324 reports
2013: 283 reports
2014: 452 reports
2015: 531 reports (excludes about 1,500 related to a class action
lawsuit on talc.)
We believe a comparison of the volume of adverse event reporting
for various product categories would not yield meaningful results,
given the breadth of FDA-regulated products and the differences in
regulatory approaches employed.
Question 4c. Does FDA prioritize investigations based on the
severity of adverse events reported to CAERS? If so, how does FDA
determine severity of adverse events?
Answer 4c. As noted in response to question 2, certain product
categories generally are considered to be more high risk (e.g., eye
area cosmetics and baby wipes). Each year, OCAC asks the field to
inspect approximately 75 to 100 manufacturers of high-risk products and
approximately 25 for cause inspections of firms with past compliance
issues (e.g., firms that manufacture products frequently associated
with adverse events reported through MedWatch). The criteria FDA uses
in determining the severity of adverse events are described in response
to question 4(d) below.
Question 4d. Does FDA categorize reports of adverse events
according to severity or other metrics? If so, please provide (1) the
range of severity, such as serious or life threatening, including
number of reports according to severity level, and (2) the range of any
other metrics that are tracked.
Answer 4d. Prioritization is based on MedWatch criteria for
``serious'' adverse events, followed by ``non-serious,'' as defined by
MedWatch (see ``What Is a Serious Adverse Event?'' at www.fda.gov/
Safety/MedWatch/HowToReport!ucm053087.htm). However, FDA also includes
permanent disfigurement, scarring, and hair loss in the criteria for
``serious'' for adverse events related to cosmetics, which is not
included in the current MedWatch definition of ``serious.''
Of the reports listed in response to Question 4b, 30 percent were
classified as serious and 70 percent as non-serious.
Question 4e. Please describe the process by which FDA identifies
clusters of adverse events reported to CAERS linked to a specific
product or ingredient.
Answer 4e. If during our review we see an increase over the typical
``background rate'' of reporting, we consider potential trends, looking
at factors such as the number of adverse events, the types of symptoms
reported, the rate at which they are reported, and patterns (for
example, cyclical. or linear increase, or intermittent). To identify
clusters linked to specific products or ingredients, we investigate
individual ingredients, formulations, routes of administration, and the
population involved.
Question 5. How many investigations has FDA opened and completed of
cosmetic products in the last 5 years due to reports of adverse events?
Please identify each enforcement or other action resulting from such
investigations.
Answer 5. In the past 5 years, FDA has conducted 13 investigations
as a result of reports of adverse events, as follows:
(1) Seven of the investigations were related to WEN by Chaz Dean
and Guthy-Renker.
(2) Two were related to EOS (Evolution of Smooth) lip balms.
Consumer information regarding the investigations has been posted on
FDA's website.
(3) One was related to Lime Crime lipsticks. A warning letter was
issued to the firm, and a recall was initiated by the firm.
(4) Three investigations were related to tattoo inks from firms
including Catfish Carl's, White and Blue Lion, and A Thousand Virgins.
These investigations resulted in recalls that were initiated by the
firms.
Question 6. How many consumer announcements has FDA issued for
cosmetic products within the last 5 years?
Answer 6. We use a variety of mechanisms to disseminate information
to advise consumers of specific safety concerns, to provide advice on
using cosmetics safely, or respond to frequently asked questions. To
ensure maximum outreach, we may use a variety of formats, such as a
Consumer Update, a MedWatch Safety Alert, or a general Web page ``fact
sheet.'' This means that any given topic may be addressed in more than
one way. We also use social media and email to further disseminate this
information.
Since the beginning of 2011, we have published 26 Web pages on
cosmetic products, ingredients, and adverse event reporting, as shown
in the table below:
FDA Web Pages About Cosmetic Products--2011--present
------------------------------------------------------------------------
Format Topics Total
------------------------------------------------------------------------
Consumer Updates.................... Adverse event 7
reporting.
Cosmetics marketed
with drug claims.
Skincare products
containing mercury.
Tattoos (3)...........
Temporary tattoos.....
MedWatch Safety Alerts.............. Bentonite clay 7
products containing
lead (2).
Microbial
contamination of
disposable wipes.
Microbial
contamination of
tattoo inks.
Eyeliners containing
lead.
Skincare product
containing mercury.
WEN cleansing
conditioners.
General Web pages................... Adverse event 12
(``Fact Sheets'') reporting.
Disposable wipes......
EOS lip balms.........
Fragrances............
Hair-smoothing
products that release
formaldehyde (e.g.,
Brazilian Blowout,
Van Tibolli).
Hair dyes &
straighteners.
Parabens..............
Talc..................
Tattoos and permanent
makeup.
Temporary tattoos/
henna/black henna.
WEN cleansing
conditioners.
Wrinkle treatments/
anti-aging products.
------------------------------------------------------------------------
Question 7a. It is our understanding that the cosmetic industry
currently relies on the Cosmetic Ingredient Review Board (CIR), an
independent board of which FDA is a member, to review the safety of
cosmetic ingredients.
Does FDA coordinate with the CIR to address reports of unsafe
ingredients or adverse events? If so, please describe such
coordination.
Answer 7a. The CIR is an industry-funded panel of scientific and
medical experts that meets quarterly to review the safety of certain
cosmetic ingredients. FDA participates on a non-voting basis. While CIR
asks FDA for ingredient frequency-of-use data from its VCRP and input
regarding priorities for ingredient review, CIR determines its own list
of priorities.
Question 7b. What actions does FDA take, if any, when CIR finds an
ingredient to be unsafe or safe with qualifications?
Answer 7b. FDA takes CIR reviews into consideration when we
evaluate cosmetic ingredient safety, but FDA's conclusions may differ
from those of CIR.
Question 7c. Could the role of the CIR be strengthened to better
provide the agency with safety data and information related to
ingredients? If so, how?
Answer 7c. Some have suggested that FDA could help improve the
stature of the CIR. FDA believes that helping to enhance the
credibility and stature of a private organization is not an appropriate
use of resources, particularly when that organization assesses the
safety of cosmetic ingredients, which is an activity within the
Agency's purview. Such activity could create the misleading appearance
that determinations made through this partnership represent FDA
determinations.
In addition, following are some of FDA's concerns regarding the
CIR:
When CIR calls for data, responses by industry
manufacturing firms and their suppliers are voluntary and selective,
and in some cases CIR does not receive responses at all to its calls
for data. Thus the resulting assessments may not be based on complete
and unbiased data.
The CIR Expert Panel reviews only summaries and
distillations of data, rather than raw data from experimental and
clinical studies. As a result, the Expert Panel evaluations may not
reveal flaws in the design and collection of the underlying data.
The CIR has no formal mechanism or timeline to resolve
determinations that data are insufficient or to ensure compliance with
final conclusions that ingredients are unsafe.
The CIR may categorically defer or exclude cosmetic
ingredients from safety assessment if they are subject to other
existing safety review mechanisms, even though these alternate review
mechanisms may not provide adequate safety substantiation in cosmetic
product applications.
Some have suggested that FDA should accept CIR safety decisions. In
addition to the concerns explained above regarding the CIR's safety
decisions, FDA has legal concerns about this suggestion based on the
constitutional principle called the non-delegation doctrine, which
stems from the vesting of ``all legislative Powers'' in Congress under
Article I, Section 1 of the U.S. Constitution. Courts have interpreted
this section of the Constitution to limit the ways in which Congress
may delegate its legislative power to other entities. For example, a
statute delegating legislative power to an executive branch agency must
supply standards for the agency to apply in exercising the delegated
power. A.L.A. Schechter Poultry Corp. v. United States, 295 U.S. 495,
529-542 (1935). The non-delegation doctrine has also been held to
restrict the transfer of regulatory functions to private entities. See,
e.g., Yakus v. United States, 321 U.S. 414, 424 (1944) (analyzing
Schecter Poultry); Carter v. Carter Coal Co., 298 U.S. 238, 311 (1936).
Thus, legislative language that deems FDA to have accepted a safety
determination by a private entity and requires FDA to enforce that
determination raises constitutional questions under the non-delegation
doctrine.
Question 7d. What additional data, if any, would be necessary or
useful for FDA to assess safety review data to better assure the safety
of cosmetic ingredients?
Answer 7d. FDA has a number of ways to monitor cosmetic products on
the market, but often the available safety information is limited:
Voluntary Cosmetic Registration Program: FDA encourages
cosmetic firms to report product formulations through the VCRP. The
VCRP database provides important information on these cosmetics.
However, the companies are not legally required to tell FDA about their
products and safety data. Receiving this information as part of a
mandatory registration program would enhance our knowledge of product
formulations and the size of the industry that FDA regulates.
Inspections: FDA can inspect manufacturing facilities to
determine if proper controls and practices are being followed. FDA also
works with U.S. Customs and Border Protection to examine imported
cosmetics. But because resources are limited, only a few establishments
are inspected each year. In addition, FDA does not have authority to
inspect records on cosmetics, as it does for all other product
categories.
Reports from consumers and health care providers: Because
the law does not require that adverse reactions (serious or otherwise)
to cosmetics be reported by cosmetic firms to FDA, we may be unaware of
problems or identify problems late.
(See ``How FDA Evaluates Regulated Products: Cosmetics,'' at
www.fda.gov/AboutFDA/ Transparency/Basics /ucm262353.htm.)
Question 7e. What additional authorities would be helpful to
strengthen FDA's authority to coordinate effectively with the Cosmetic
Ingredient Review board and utilize its safety findings to better
protect public health?
Answer 7e. We have not identified any additional authority that is
needed to coordinate with CTR. Please note our concerns about CIR
review in 7c.
Question 8. Please provide a breakdown of FDA's resources allocated
to cosmetic regulation activities over the last 5 years, including, but
not limited to, activities related to inspections, enforcement, sample
collection, and safety investigations.
Answer 8. The CFSAN cosmetics program includes safety evaluation
and post-market surveillance, compliance oversight, regulatory
guidance, voluntary product registration, cosmetics safety research,
and stakeholder education and outreach.
Please see the following table for a breakdown of FDA's resources
supporting cosmetic regulation activities. FDA conducts activities by
organization. A brief description of activities conducted by the Center
for Food Safety and Nutrition (CFSAN), the Office of Regulatory Affairs
(ORA), and the National Center for Toxicological Research (NCTR) is
also provided below.
FDA Cosmetics Resources
($ in millions, rounded to the nearest $0.1 million)
----------------------------------------------------------------------------------------------------------------
FY 2012 FY 2013 FY 2014 FY 2015 FY 2016
Organization Actual Actual Actual Actual Estimate
----------------------------------------------------------------------------------------------------------------
CFSAN..................................... 7.8 7.9 9.4 7.4 8.1
ORA....................................... 3.3 3.6 4.1 4.1 4.5
NCTR...................................... 0.5 0.8 3.0 0.9 1.1
Total................................. 11.6 12.3 16.5 2.4 13.8
----------------------------------------------------------------------------------------------------------------
ORA conducts inspections, investigations, recall activities, field
examinations, sample collections and laboratory analysis in support of
the Cosmetics Program. These activities are executed to determine if
domestic cosmetic manufacturing or repacking establishments, and
cosmetics offered for importation, comply with the FD&C Act and
regulations enforced by the FDA. Both domestically manufactured and
imported products must be safe under intended conditions of use,
properly labeled, and not otherwise adulterated or misbranded under the
provisions of the Act.
NCTR conducts research to generate data that FDA reviewers can use
to assess the safety of existing ingredients, and some product
categories (such as nanomaterials and tattoo inks.) NCTR also conducts
chronic/long-term exposure studies relating to selected compounds found
in some personal care products.
Question 9. Does the agency plan to finalize the draft guidance for
industry on Cosmetic Good Manufacturing Practices which was updated in
June 2013? If so, when?
Answer 9. Yes. The Agency is aware of the need to move forward
regarding the draft guidance. However, FDA cannot currently estimate
exactly when this will be finished due to resource constraints and
other competing public health priorities.
Thank you, again, for contacting us concerning this matter. Please
let us know if you have any further questions.
Sincerely,
Acting Associate Commissioner for Legislation.
Response by Beth Lange Jonas, Ph.D. to Questions of Senator Alexander,
Senator Murray, Senator Enzi, and Senator Hatch
senator alexander
Question 1. In your testimony, you stated that 2,000 new personal
care products are launched annually, and that products can take up to 2
years to develop. What are the different stages of development that a
product must go through?
Answer 1. A top priority for our industry is to provide innovative,
safe products to the families who enjoy them every day. Many steps are
taken and chemistries considered in the development of a new product
beginning with:
defining a product concept; selecting appropriate
ingredients and formulation technologies;
developing processes for scaling up the product from a
small beaker in the lab to huge vats while ensuring quality control is
maintained no matter where it is manufactured in the world;
consumer and clinical evaluation to ensure the product
delivers on the claims and benefits that are expected from the product;
supply chain to plan and purchase the materials needed to
make the finished product, including raw materials, packaging, and
labeling.
Importantly, safety is factored into every step from ingredient
selection, packaging choices, final formula assessment, and post market
surveillance.
Question 2a. Are there accompanying safety assessments that take
place at each stage of product development?
Answer 2a. Yes, safety is considered throughout every stage of the
product development cycle. Safety assessment begins with the
qualification of raw materials, to assuring the safety of the finished
products, following through to post-market monitoring of consumer
feedback. Safety assessments are continually updated through monitoring
and careful consideration of all the scientific literature that is
available.
The industry employs nearly 6,000 scientific and technical
professionals dedicated to ensuring product and ingredient safety.
Companies also work with scientific and medical experts--chemists,
toxicologists, microbiologists, dermatologists, epidemiologists,
environmental scientists and other technical experts--to evaluate and
ensure the safety of their products before they reach the consumer. In
addition to outside experts, companies use pre-clinical and clinical
safety testing as a means to substantiate the safety of both
ingredients and finished cosmetic products. Pre-clinical testing may
include in vitro alternative methods using cell and tissue cultures
following accepted regulatory guidelines when available.
In silico methods, such as the use of structure-activity
relationships, may add to the overall weight of the evidence for safety
evaluation. Clinical testing with human volunteers confirms safety.
Once the relevant safety data is assembled, a risk assessment is
conducted to see if the data provide an adequate margin of safety given
the particular exposure circumstances.
Companies conduct product safety evaluations using the same
science-based approaches embedded in the research practices at FDA,
EPA, and other regulatory agencies around the world. Cosmetic safety
assessments are thorough and address numerous health questions,
including, but not limited to the potential for cancer, reproductive
harm, allergic reactions, and how an ingredient is cleared if it goes
through the body. The foundation of science-based safety assessments is
that any ingredient has a safe range and an unsafe range whether it is
water, or a vitamin, or a newly discovered compound. An ingredient's
safe range is defined through many, many studies before it can be used
in a product. Safety is about choosing ingredients that can be used
safely, and avoiding ingredients that cannot be used safely. A complete
safety assessment accounts for who uses the products, how they are used
and how often, over a lifetime. Finally, companies' post market
surveillance of the consumer experience acts to affirm product safety.
Question 2b. How does a company select a raw ingredient and have
confidence that such ingredient is safe?
Answer 2b. Raw material selection is based on many factors
including quality, functionality, cost, availability and safety. To
address safety, there are many sources of information relevant to
cosmetic ingredients. These include information from the material
supplier, government testing and relevant regulatory approvals, the
scientific literature about the ingredients and closely related
ingredients, and the company's own data and experience. Important
resources also are considered from independent review bodies such as
the Cosmetic Ingredient Review in the U.S. and the Scientific Committee
on Consumer Safety in the EU--these provide safety assessments specific
to ingredient use in cosmetics. After the raw material has been
selected, acceptance criteria are established to ensure incoming supply
consistently meets technical and quality requirements.
Question 3a. Does the process for ensuring an ingredient is safe
differ depending on whether the ingredient is new to the market as
opposed to an ingredient with a long history of use?
Answer 3a. The process of assessing safety does not differ;
however, a known cosmetic ingredient will have data already available
whereas new ingredients might require data development.
Question 3b. To the extent the process differs, please describe how
such differences affect a company's process for deciding whether to use
an ingredient.
Answer 3b. Most cosmetic ingredients are also used in other
consumer products such as foods, drugs, etc. and so have been already
subjected to extensive and intensive reviews. When a new ingredient is
identified, a full safety assessment needs to be developed.
Question 4. Congress has prohibited cosmetics manufacturers from
putting harmful ingredients in their products, and the FDA enforces
that prohibition in part by maintaining a list of ingredients that are
either prohibited or restricted for certain uses. Currently, there are
only nine ingredients on FDA's list. CIR maintains a long, published
list of ingredients that it has reviewed and found to be safe, but with
certain restrictions on how they may be used. Could FDA be doing more
under its current authorities to leverage the work that CIR is already
doing to evaluate the safety of ingredients?
Answer 4. Yes. The industry fully supports and encourages FDA to
utilize CIR findings.
Question 5. Dr. Bergfeld testified that when CIR reviews an
ingredient or group of ingredients, it issues a finding of safe, safe
for use with certain restrictions, unsafe for use in cosmetics, or
lacking sufficient data to determine safety. How does a company account
for each of these four types of safety findings when working to
formulate new or continuing to develop personal care products?
Answer 5. CIR information is publicly available at http://www.cir-
safety.org. A company can examine the published safety assessment to
find the conclusion regarding the material. If they choose to use the
ingredient in a way not addressed by the CIR recommendation, the
company will need to ensure their own safety data on file supports the
safe use of the ingredient in the product.
senator murray
Question 1a. In July, FDA announced it had received 127 adverse
event reports about WEN hair products through its voluntary reporting
system for consumers and clinicians. After further investigation, FDA
found that the maker of WEN had actually received more than 21,000
consumer complaints about the product--but under current law, the
company did not have to report these to the FDA.
How do companies distinguish between consumer complaints and
adverse event reports, and do you believe that most companies report
adverse events to the FDA?
Answer 1a. Consumer complaints and adverse reports provide valuable
information for cosmetic companies in validating the safety and
performance of their products in the marketplace. The typical post-
market surveillance process includes a consistent survey of consumers
received by a manufacturer either through toll-free numbers, websites,
or direct correspondence. There is currently no obligation to report
adverse events from cosmetics to the FDA. Under the PCPC Consumer
Commitment Code, member companies commit to submitting serious adverse
events to the FDA.
In addition, through the Consumer Commitment Code our members
commit to GMPs; of which a documented procedure for consumer complaint
handling is an important element. After consumer comments are recorded
in the intake system, they are typically segregated by a Quality
Control Unit that distinguishes those related to product quality from
those which are related to a potential adverse event. Potential adverse
events are further evaluated by a cross-functional team consisting of
relevant experts.
Question 1b. What assurances do consumers have that all companies
are classifying adverse events correctly and reporting them to the FDA?
Answer 1b. FDA provides resources to companies to help classify
adverse events: http://www.fda.gov/AboutFDA/Transparency/Basics/
ucm286540.htm. FDA also provides a definition for serious adverse
events: http://www.fda.gov/Safety/MedWatch/HowToReport
/ucm053087.htm which is also incorporated in the Council's Quality
Assurance Guidelines in the chapter on Consumer Complaints Systems.
Question 2. Many companies in the cosmetic industry and consumer
groups have their own lists of ``safe'' and ``unsafe'' ingredients.
What standards do you use to create these lists for the organizations
you represent?
Answer 2. Some companies develop internal lists of ``prohibited''
or ``restricted'' ingredients. Some of these lists are based on the
level of safe ingredient as allowed by the strictest regulatory body in
the country where they are market. Other reasons are unrelated to
safety and reflect brand identity such as forbidding animal derived
ingredients, restricting certain plant products or ingredients not
preferred due to religious (i.e. alcohol for Halal) or other consumer
preferences.
Question 3. Products such as the ``Brazilian Blowout'' remain on
the market despite the fact that CIR and the FDA found that the
formaldehyde content was unsafe. Why and how are companies still
marketing products even after CIR and the FDA found formaldehyde to be
unsafe?
Answer 3. While the FDA currently has the regulatory authority to
take action, the Council fully supports legislative modernization to
provide FDA with increased authority and funding to take appropriate
action.
Question 4a. Some businesses single-source their ingredients,
formulations, and manufacturing facilities to control the quality of
the product and ensure that there is no cross-contamination by
potential allergens or other ingredients. I understand, however, that
this is not the norm in the industry. Please explain the supply chain
that cosmetics ingredients and finished products move through.
Answer 4a. Prevention of cross-contamination is the norm in the
industry and is embodied within current Good Manufacturing Practices
(GMPs). GMPs establish systems designed to ensure quality products meet
the highest standards. Supply Chain includes managing all the
activities involved in responsibly sourcing and producing a product.
Step one in the process is planning. Strategies are developed to manage
resources for timely delivery of raw materials, packaging, applicators,
labels, and finally products. Choosing suppliers is the next step. This
includes ensuring supplier quality criteria can be met and developing a
system for pricing, delivery and payment. Manufacturing is the next
step. After acquiring the right raw material, a company must make
careful decisions on the manufacturing of the product. The demand for
the product, technologies required and other important decisions are
carefully managed during this stage. During manufacturing, activities
focus on production, testing, packaging and preparation for delivery of
goods to customers. Delivery, or logistics, is the stage of supply
chain management where warehouse plans and transportation are
considered. Logistics plan, execute and control various aspects of
supply chain, from the point of origin to the point of consumption.
Oversight of the entire supply chain, with routine quality checks among
business partners, is an integral part of GMPs to ensure the safety and
quality of the final product.
Question 4b. How do external formulators and manufacturers work
together with cosmetic and personal care product companies to inform a
final product?
Answer 4b. The selection of an external contractor typically
involves a thorough review and evaluation of the contractor's
capabilities, and often includes an inspection of the contracted
operation. Prior to engaging in any part of production, quality
requirements should be well-defined and understood by the
subcontractor, and formalized in a quality agreement that describes the
expectations and responsibilities of each party. Once an external
contractor is identified and qualified, then a product brief is
developed by the personal care product company which outlines the
expectations for the product being developed. From there, it is an
iterative process to develop an acceptable final product.
Question 4c. What safeguards do companies employ to ensure that
products do not become contaminated with allergens from other products?
Answer 4c. Prevention of cross-contamination is the norm in the
industry and embodied within current Good Manufacturing Practices
(GMPs). GMPs establish systems designed to ensure that products are
consistently produced according to quality standards with the goal of
consumer safety and product performance and acceptability.
The establishment, implementation, and enforcement of GMPs are
essential elements in cosmetic and personal care product manufacturing.
GMPs encompass all aspects of production, from the premises and
equipment to the training of qualified staff.
The Council's Quality Assurance Guidelines provide a framework for
establishing systems and procedures that are necessary to achieve a
high level of product quality, and avoid problems that could adversely
affect the product, including adulteration of that product.
Question 4d. How do companies test for allergenicity in their final
products?
Answer 4d. Cosmetic formulations may be evaluated in the Human
Repeated Insult Patch Test (HRIPT). For ethical reasons, the HRIPT
should not be used as a predictive assay to evaluate the skin
sensitization hazard of a chemical or a formulation. It can, however,
be used, to confirm absence of sensitization potential of a chemical or
formulation, after thorough consideration of relevant information such
as preclinical test data, human exposure conditions, and patch test
conditions. Many materials that are potential sensitizers as raw
materials, at some dose, will not induce sensitization in finished
formulations. This is due to a lower exposure based on a dose per unit
area concentration. Therefore, the majority of cosmetic formulations
can be tested safely under the informed consent of the subject, while
carefully controlling exposure conditions. Favorable testing results
assure minimum risk of induction of sensitization in large populations
of consumers using products under normal and foreseeable conditions.
Question 5a. Some products like hair straighteners, and gel and
acrylic nail products, are used on consumers by a professional. Some of
these contain harsh chemicals--and present a unique risk to the
professional who is being continuously exposed to the product, as was
highlighted by a New York Times investigation into the safety of nail
salons.
What are some of the long term health consequences of handling some
of these professional products every day, and what is being done by the
manufacturers to protect workers?
Answer 5a. Through training and education the ingredients
referenced in these examples can be used safely when used as directed.
OSHA requires employers to provide very specific information,
protective gear and training to ensure the safe use of these
ingredients in the workplace.
Question 5b. When formulating products meant for use by a
professional, do companies consider how these chemicals may impact the
long term health of those handling them every day at work?
Answer 5b. Yes, for example, professional nail care products are
formulated to minimize exposure and the potential for adverse health
effects. Also, nail salon products are typically used in small amounts,
which can further lower the risk of overexposure. These materials can
be used safely. Additionally, OSHA requires Safety Data Sheets contain
information for people working in many occupations including factory
workers, shippers, warehouse employees, emergency responders, and
doctors, as well as nail professionals who use these products to
perform salon services.
Question 6. Together, PCPC and ICMAD represent almost all of the
cosmetic companies in the United States. Members of PCPC must agree to
a Consumer Commitment Code and ICMAD members must adhere to a Code of
Ethics, both of which state that the company will prioritize product
quality and safety. What tools do PCPC and ICMAD use to ensure that its
members uphold their commitment to consumers?
Answer 6. In 2007, the Personal Care Products Council established a
Consumer Commitment Code that was adopted unanimously by its board of
directors. In the initial years of its implementation, the Council
conducted educational and outreach programs so its member companies
could understand and adopt the Code as standard business practice.
Since its inception, the Consumer Commitment Code continues to
serve as the Council's foundation and provides educational
opportunities for members to understand and fully support its
requirements.
I cannot speak for what actions might be taken by ICMAD on their
Code of Ethics with their members.
senator enzi
Question 1a. The Personal Product Safety Act includes packers and
holders in its definition of a ``facility'' which has raised concerns
about the fee payment obligations.
Please provide specific examples of cosmetic products which have
become contaminated while in transit, under the authority of a packer
or a holder, or a contract manufacturer.
Answer 1a. I am unaware of any instances.
Question 1b. What safeguards could be put in place to ensure that
packers, holders, and contract manufacturers, are not paying fees that
have already been paid by manufacturers?
Answer 1b. The Personal Care Products Council does not represent
packers and holders, so this is outside my scope of expertise.
Question 2a. There was no discussion during the hearing about how
the Personal Care Product Safety Act would affect the cost of insurance
for the cosmetic industry.
How do the insurance premiums of cosmetic companies compare to
other FDA regulated product categories?
Answer 2a. This is outside my scope of expertise.
Question 2b. What is the average premium for a cosmetic company
which has gross annual domestic sales of $100,000?
Answer 2b. This is outside my scope of expertise.
Question 2c. What is the average premium for a cosmetic company
which has gross annual domestic sales of $500,000?
Answer 2c. This is outside my scope of expertise.
Question 3a. The Personal Care Product Safety Act mandates
registration with the Food and Drug Administration (FDA) of all
facilities which engage in manufacturing or processing of a cosmetic
product or a cosmetic formulation distributed in the United States. The
act excludes in its definition of a ``facility'' those domestic
cosmetic manufacturers who had less than $100,000 in gross annual sales
of cosmetic products.
Is the $100,000 gross annual sales threshold an adequate standard
for the definition of a ``facility?''
Question 3b. What specific industries have expressed concern over
the $100,000 threshold in the definition of ``facility?''
Question 3c. Have any specific industries advocated for a higher
annual sales threshold in the definition?
Answer 1a, 1b, and 1c. I am not aware of how these thresholds came
to be used in the Personal Care Product Safety Act and am not aware of
specific industries advocacy for these thresholds.
Question 4a. The Personal Care Product Safety Act states that
cosmetic ingredient statements shall be submitted to the FDA for each
cosmetic product. However, it allows for the FDA to permit a simplified
cosmetic ingredient statement for those businesses which average less
than $500,000 in annual domestic cosmetic sales over a 3-year period.
What is the average number of individuals employed by cosmetic
companies which average $500,000 in domestic sales over a 3-year
period?
Question 4b. Have any specific industries expressed concern over
the $500,000 threshold?
Question 4c. Have any specific industries publicly or privately
advocated for a higher threshold to qualify for a simplified ingredient
statement?
I am not aware of how these thresholds came to be used in the
Personal Care Product Safety Act and am not aware of specific
industries advocacy regarding these thresholds.
Answer 4a, 4b, and 4c. I am not aware of how these thresholds came
to be used in the Personal Care Product Safety Act and am not aware of
specific industries advocacy for these thresholds.
senator hatch
Question. FDA has a draft guidance on cosmetic good manufacturing
practices, which they initially published in 1997 and have revised
twice since then, once in April 2008 and again more recently in June
2013. If FDA were to finalize this guidance, or require manufacturers
to comply through rulemaking, how would it provide greater clarity for
the full range of manufacturers regarding best practices for
manufacturing safe cosmetic and personal care products? If the FDA is
updating its thinking in its regulatory capacity, I would think that
finalizing guidance provides more certainty for the industry than
having a lingering updated draft guidance.
Answer. We support FDA finalizing a cosmetic GMP guidance
consistent with international standards as embodied in ISO 22716,
Cosmetics Good Manufacturing Practices. Specific to FDA's 2013 draft
guidance on cosmetic good manufacturing practices, industry hopes FDA
will take into account our comments urging complete alignment with ISO
22716.
Response by Wilma Bergfeld, M.D.\1\ to Questions of Senator Alexander,
Senator Murray, Senator Enzi, Senator Hatch, Senator Murphy, and
Senator Warren
---------------------------------------------------------------------------
\1\ As an independent CIR Expert Panelist and board certified
dermatologist, I am not privy to individual company practices nor would
it be appropriate for me to comment on legislation or its potential
impacts unless specifically related to CIR. My answers reflect my
knowledge and work as part of the Cosmetic Ingredient Review Panel.
---------------------------------------------------------------------------
senator alexander
Question 1. How does the Cosmetic Ingredient Review (CIR) determine
which ingredients it will review each year?
Answer 1. Initially, CIR identified ingredients for review by known
biological activity or by stakeholder request. Once the review of that
list of ingredients thought to have a significant biological activity
began to decline significantly in number, CIR began to supplement each
year's agenda with selected ingredients based on frequency of use. Each
year, CIR develops a priority list of ingredients that are recommended
for review. This list is available for public comment and discussed in
open Expert Panel meetings multiple times before it is finalized by the
Expert Panel. There are three primary criteria for adding an ingredient
to the annual CIR Priority List.
1. The first one is ``for cause.'' Ingredients may be nominated for
inclusion for specific concerns from multiple sources. Requests may be
made by stakeholders, such as the FDA, Members of Congress, consumer
groups, members of industry, members of the CIR staff, members of the
CIR Expert Panel, and members of the general public.
2. The second criterion is the frequency of use (FOU) of
ingredients not previously reviewed by CIR. The process of selecting
ingredients based on how many products an ingredient is used in,
according to the FDA Voluntary Cosmetic Registration Program (VCRP).
Higher FOU ingredients get higher priority.
3. The third criterion that may invoke a safety assessment by the
CIR Expert Panel is ``Re-review.'' A re-review or re-assessment of the
safety of ingredients or a family of ingredients previously reviewed by
CIR may be triggered either by a request, as above, or the aging of the
previous review to 15 years (i.e., CIR reviews the safety again to see
if new data or information would change their original conclusion.
In addition, ingredients that meet one of the criteria above may be
grouped with other ingredients in a report, where appropriate. Those
potential groupings are presented to the CIR Expert Panel, along with
those ingredients that meet one of the above criteria, during the
priorities setting process for approval.
Question 2. When CIR hears concerns or receives information about
health effects related to specific cosmetic ingredients, how does CIR
take that information into account in determining or prioritizing which
ingredients it will review?
Answer 2. CIR regards all information about health effects related
to specific cosmetic ingredients to be crucial for considering the safe
use of these ingredients in cosmetic products, including a request to
review and ingredient ``for cause.'' CIR will provide the information,
and any additional background on the ingredient, in the Panel meeting
package (publicly available on-line), highlight the new information in
the Expert Panel memo and include the discussion of the information on
the agenda. After discussion the Expert Panel determines the need for
further assessment of the ingredient of concern and the priority of
review.
The Expert Panel may at any time revise the final annual priority
list to add new ingredients or to revise the prioritization of existing
ingredients. The Expert Panel may, on its own initiative, or at the
request of the Chair of the CIR Steering Committee or FDA, or in
response to public comment, assign a special priority for and undertake
a review of any ingredient(s) that has been identified as deserving
expedited review for use in cosmetics.
Question 3. In your testimony, you noted that after CIR reviews the
relevant data and literature, CIR classifies ingredients as safe as
used, safe with certain use restrictions, unsafe for use in cosmetics,
or lacking sufficient data to determine safety. Does CIR send these
findings to the Food and Drug Administration (FDA) for review? If so,
what action does FDA take related to these findings?
Answer 3. Since the formation of the CIR in 1976, the Food and Drug
Administration has had a designated liaison representative, a non-
voting member, on the CIR Expert Panel. For over 20 years, the FDA
liaison has been seated with the Panel as one of 3 non-voting members
(the Consumer Federation of America representing consumers and the
Personal Care Products Council representing the industry Liaisons are
the others) who are responsible for providing the views, opinions and
contributions of the organizations that they represent. Panel members
(including the liaisons) and the Public receive identical information
about the ingredients assessed, including pre-meeting and post-meeting
materials and participate in all CIR Expert Panel meetings.
CIR sends to the FDA the post meeting announcements, which
summarize the discussions and decisions of the Expert Panel that are
prepared after each meeting. The CIR Expert Panel conclusions
constitute only one part of the totality of information that the agency
may consider in deciding how best to meet their regulatory
responsibilities. FDA may take further regulatory activity based on the
outcome of the Expert Panel meeting however, CIR may not always be
aware of those activities.
Question 4. How many cosmetic ingredients has CIR found to be safe
but with certain use restrictions? Please describe, in general, the
types of use restrictions that CIR has found necessary.
Answer 4. The CIR Expert Panel may determine that an ingredient
used as described by the available data in a safety assessment, safe
for use or safe if used with certain qualifications or restrictions.
To date, the Expert Panel has issued 2,569 safe with qualifications
conclusions. The majority of these determinations specify that use of
the ingredient is safe when formulated to be non-irritating. Other
qualifications of ingredient use can include: safe use when formulated
by the manufacturer to be non-sensitizing; restriction on use of the
ingredient in products where N-nitroso products may be formed;
restriction of the concentration of the ingredient in formulation;
restriction by product type; and restrictions on impurities in the
ingredient, concentration of residual solvent from the manufacture of
the ingredient, or the type of solvent used in production.
Question 5. How many cosmetic ingredients has CIR found to be
unsafe for use?
Answer 5. Twelve ingredients have been found unsafe. Of these, 5 of
the ingredients have been determined to be safe with restrictions for
certain uses and unsafe for other uses.
Question 6. How could the relationship between FDA and CIR be
strengthened?
Answer 6. The relationship between FDA and CIR could be
strengthened by enhancing communication and information sharing. FDA
has worked, and continues to work, cooperatively with the CIR,
providing comments and reports of technical studies, and has provided
recommendations of ingredients that CIR should consider for evaluation.
Specific ways that CIR and FDA could better work together include
the development of a better framework for the flow of adverse event
reporting from consumers to FDA to CIR so that the information is
available to CIR and the Expert Panel. Additionally, it may be
beneficial to have a more formalized process for the FDA to acknowledge
CIR safety assessments and to act upon those reports as the Agency
deems necessary. For example, FDA could explore the significance and
impact of insufficient data conclusions from a regulatory perspective
and determine what agency response might be appropriate. Also, they may
utilize the many CIR ingredient safety conclusions, where the decisions
indicate that there is no evidence of safety concerns, to abbreviate
FDA's own process and very quickly conclude on a great multitude of
ingredient safety profiles.
Question 7. How many ingredients does CIR review on average per
year? How does this number reflect similar ingredients that may be
considered part of the same ``family?''
Answer 7. Ingredients selected for review may be selected from the
INCI Dictionary based on prioritization criteria, such as those
recommended by stakeholders, or those selected for their high frequency
of use. A re-review or re-assessment of the safety of ingredients or a
family of ingredients previously reviewed by CIR may be triggered
either by a request, as above, or the aging of the previous review to
15 years (i.e., CIR reviews the safety again to see if new data or
information would change their original conclusion. However,
ingredients may be re-reviewed sooner for cause (e.g., requested by a
stakeholder) or if their re-review with a group of previously reviewed
ingredients may be informative to some part of the safety assessment
process. In other words, CIR may combine like ingredients into a single
safety assessment, including some that were previously reviewed, for
efficiency and compatibility purposes. Thus for any given year, the CIR
workload may consist of individual ingredients that have not been
previously reviewed by the Panel, individual ingredients that have been
reviewed and are candidates for the 15-year re-review cycle, and groups
or ``families'' of similar ingredients that may contain ingredients
that have not been reviewed and those that have been previously
reviewed. Added to this complexity is the potential for some
ingredients to receive split, or multi-part conclusions.
Based on these factors, CIR reviewed an average of 500 ingredients
per year for the past 5 years. These ingredients are assessed in an
average of 20 reports per year, most of which comprise multiple
ingredients that constitute ingredient ``families.''
Question 8. What safety criteria or toxicological information do
the panel members of CIR consider when reviewing and assessing the
safety of ingredients?
Answer 8. The Panel assesses the ingredient safety based on use in
cosmetics (i.e., concentration of use as well as types of exposure).
After reviewing the use data, the Panel considers safety using
information on some or all of the following criteria, as deemed
appropriate: composition and impurities data, dermal penetration data,
toxicokinetics studies, single and repeated dose studies (taking into
consideration the route of exposure that is applicable), developmental
and reproductive toxicity data, genotoxicity data, carcinogenicity
data, dermal irritation and sensitization data. If additional types of
data are needed to assess safety, the Panel will request those data;
the data request and the rationale for the additional need is made
publicly available.
Question 9. The Personal Care Products Council established CIR in
1976. You stated in your testimony that, while CIR is funded by the
industry, members of its Expert Panel must ``meet the same conflict-of-
interest standards as those of FDA advisory committee members.'' Please
describe in detail the specific conflict-of-interest requirements that
apply to members of the CIR Expert Panel, as well as any other
practices in place to ensure that CIR maintains an independent process
in evaluating the safety of ingredients.
Answer 9. CIR activities are governed by the Cosmetic Ingredient
Review Procedures (http://www.cir-safety.org/sites/default/files/
pdf1.pdf). According to the procedures, members of the Expert Panel are
required to meet the same conflict of interest standards as are
applicable under Federal Law, particularly those of FDA advisory
committee members.
senator murray
Question 1a. In July, FDA announced it had received 127 adverse
event reports about WEN hair products through its voluntary reporting
system for consumers and clinicians. After further investigation, FDA
found that the maker of WEN had actually received more than 21,000
consumer complaints about the product--but under current law, the
company did not have to report these to the FDA.
How do companies distinguish between consumer complaints and
adverse event reports, and do you believe that most companies report
adverse events to the FDA?
Question 1b. What assurances do consumers have that all companies
are classifying adverse events correctly and reporting them to the FDA?
Answer 1a and 1b. The content of this question is outside the scope
of the CIR mission. FDA, or members of the cosmetic industry, may
provide the information you are seeking.
Question 2. Many companies in the cosmetic industry and consumer
groups have their own lists of ``safe'' and ``unsafe'' ingredients.
What standards do you use to create these lists for the organizations
you represent?
Answer 2. The content of this question is outside the scope of the
CIR mission. These companies may provide the information you are
seeking.
Question 3a. Many consumers and families are rightly concerned
about the long-term health effects of exposure to very low doses of
cosmetic ingredients from the products that they use each day, year
after year.
What studies need to be done to answer consumers and families'
questions about long-term health effects, like endocrine disrupting
effects, of cosmetic ingredients?
Answer 3a. The CIR Expert Panel bases its safety assessments on a
comprehensive search of the scientific literature and data submitted by
stakeholders to evaluate all exposure scenarios applicable to consumer
use of cosmetics (comprising all relevant types of personal care
products) and potential toxicity endpoints (i.e., adverse health
effects). The scenarios considered include long-term (i.e., essentially
lifetime) exposures to an ingredient at maximum reported concentrations
in personal care products used as often as multiple times a day.
The potential adverse health effects considered include the full
range of possible toxicity endpoints, including potential carcinogenic
effects after long-term exposures and potential developmental and
reproductive effects after long-term exposures and after short-term
exposures during critical stages of reproduction and development (e.g.,
pregnancy). As physicians, toxicologists, and other experts in the
health sciences, the Panel knows the importance of the endocrine system
in reproduction, development and, generally, in maintaining good
health. The Panel is also mindful of the potential for disruptions of
the endocrine system to cause adverse health effects. CIR is constantly
monitoring and reviewing the literature and the efforts of regulatory
bodies and scientific workgroups and advisory boards addressing the
potential for cosmetic ingredients to disrupt the endocrine system. The
Panel considers all of the available scientific information from
epidemiological, test-animal, and in vitro studies to evaluate the
potential for endocrine effects in its assessments of specific
ingredients and ingredient groups.
A safe as used conclusion for an ingredient in a CIR safety
assessment indicates a negligible risk of chronic and acute health
effects after long-term, daily exposures to the ingredient at its
greatest reported concentrations in cosmetic products, when these
products are used as intended.
Question 3b. Are those the type of studies that CIR reviews when
determining whether an ingredient is safe?
Answer 3b. Yes. CIR reviews acute, short-term, and chronic toxicity
studies performed in vivo on mammalian test species, in vitro studies
using animal or human cells and tissues, and epidemiological studies to
assess the potential for ingredients to cause any possible adverse
health effects. These effects include dermal, ocular, and mucous-
membrane irritation, sensitization (allergies), and phototoxicity after
short-term or long-term exposures. The effects also include
genotoxicity, cancers, reproductive and developmental effects, and
endocrine effects. As well, the Panel reviews studies of the potential
for neurotoxicity, immunotoxicity and other end-points, as relevant and
appropriate for assessing the safety of ingredients, as used in
cosmetics.
Question 3c. Please explain the discrepancy between conclusions
reached by regulators in Europe and those reached by CIR in the
interpretation of available scientific data about whether certain
ingredients are safe for use.
Answer 3c. There are many possible reasons why CIR might reach a
conclusion that differs from that of regulators in Europe, including
differences in safety assessment scope, methodologies, exposure
assumptions, and use data, as well as differences in mandates and
policies.
CIR focuses on assessing the safety of ingredients, as used in
cosmetics (comprising personal care products, as defined by FDA and CIR
policies and procedures), based solely on a comprehensive review of the
relevant scientific literature, sound scientific principles, reasonable
worst-case exposure scenarios, and the professional, expert knowledge,
experience, and judgment of the distinguished members of the Panel.
The decisions of regulators and advisory groups in Europe often
appear to be driven by the desire to eliminate all possible risks to
human health and safety by banning or severely restricting the use of
the ingredient.
For example, the European Union categorically banned the use of the
biocide preservative methylisothiazolinone (MI) in leave-on cosmetics,
because of increasing incidences of skin sensitization to MI in Europe.
The increase is attributable to the high concentrations of MI used
primarily in antibacterial wipes and other non-cosmetic products in
Europe.
The CIR Expert Panel noted the dwindling number of preservatives
that are available for use in cosmetics in Europe, a situation that has
been referred to as the ``preservative crisis.'' The Panel noted the
well-documented potential for bacterial contamination of cosmetics
during use, particularly cosmetics like mascara that are used near the
eyes, to damage the cornea and cause blindness. They noted the
scientifically based, predictive, quantitative risk assessment (QRA)
methodology that is available to calculate concentrations of MI that
would not induce sensitization in people using cosmetics containing MI.
CIR's conclusion was that ``MI is safe for use in rinse-off cosmetic
products at concentrations up to 100 ppm and safe in leave-on cosmetic
products when they are formulated to be non-sensitizing, which may be
determined based on a quantitative risk assessment (QRA).''
In contrast, the European Union banned the use of MI use as a
preservative in leave-on cosmetic products, and is restricting the use
of MI to 15 ppm in rinse-off products. The unwarranted banning of MI in
leave-on cosmetics will likely exacerbate the ``preservative crisis.''
Furthermore, it is not clear that the overly restrictive 15 ppm limit
on MI in rinse-off products in Europe will be high enough to protect
consumers from microbial contamination and growth in such products.
Question 4. Products such as the ``Brazilian Blowout'' remain on
the market despite the fact that CIR and the FDA found that the
formaldehyde content was unsafe. Why and how are company's still
marketing products even after CIR and the FDA found formaldehyde to be
unsafe?
Answer 4. The content of this question is outside the scope of the
CIR mission, as CIR has no regulatory authority. FDA, or members of the
cosmetic industry, may provide the information you are seeking.
senator enzi
Question 1a. The Personal Product Safety Act includes packers and
holders in its definition of a ``facility'' which has raised concerns
about the fee payment obligations. Please provide specific examples of
cosmetic products which have become contaminated while in transit,
under the authority of a packer or a holder, or a contract
manufacturer.
Question 1b. What safeguards could be put in place to ensure that
packers, holders, and contract manufacturers, are not paying fees that
have already been paid by manufacturers?
Answer 1a and 1b. The content of these questions is outside the
scope of the CIR mission. FDA, or members of the cosmetic industry, may
provide the information you are seeking.
Question 2a. There was no discussion during the hearing about how
the Personal Care Product Safety Act would affect the cost of insurance
for the cosmetic industry. How do the insurance premiums of cosmetic
companies compare to other FDA regulated product categories?
Question 2b. What is the average premium for a cosmetic company
which has gross annual domestic sales of $100,000?
Question 2c. What is the average premium for a cosmetic company
which has gross annual domestic sales of $500,000?
Answer 2a, 2b, and 2c. The content of these questions is outside
the scope of the CIR mission. FDA, or members of the cosmetic industry,
may provide the information you are seeking.
Question 3a. The Personal Care Product Safety Act mandates
registration with the Food and Drug Administration (FDA) of all
facilities which engage in manufacturing or processing of a cosmetic
product or a cosmetic formulation distributed in the United States. The
act excludes in its definition of a ``facility'' those domestic
cosmetic manufacturers who had less than $100,000 in gross annual sales
of cosmetic products. Is the $100,000 gross annual sales threshold an
adequate standard for the definition of a ``facility?''
Question 3b. What specific industries have expressed concern over
the $100,000 threshold in the definition of ``facility?''
Question 3c. Have any specific industries advocated for a higher
annual sales threshold in the definition?
Answer 3a, 3b, and 3c. The content of these questions is outside
the scope of the CIR mission. FDA, or members of the cosmetic industry,
may provide the information you are seeking.
Question 4a. The Personal Care Product Safety Act states that
cosmetic ingredient statements shall be submitted to the FDA for each
cosmetic product. However, it allows for the FDA to permit a simplified
cosmetic ingredient statement for those businesses which average less
than $500,000 in annual domestic cosmetic sales over a 3-year period.
What is the average number of individuals employed by cosmetic
companies which average $500,000 in domestic sales over a 3-year
period?
Question 4b. Have any specific industries expressed concern over
the $500,000 threshold?
Question 4c. Have any specific industries publicly or privately
advocated for a higher threshold to qualify for a simplified ingredient
statement?
Answer 4a, 4b, and 4c. The content of these questions is outside
the scope of the CIR mission. FDA, or members of the cosmetic industry,
may provide the information you are seeking.
senator hatch
Question 1. FDA has a draft guidance on cosmetic good manufacturing
practices, which they initially published in 1997 and have revised
twice since then, once in April 2008 and again more recently in June
2013. If FDA were to finalize this guidance, or require manufacturers
to comply through rulemaking, how would it provide greater clarity for
the full range of manufacturers regarding best practices for
manufacturing safe cosmetic and personal care products? If the FDA is
updating its thinking in its regulatory capacity, I would think that
finalizing guidance provides more certainty for the industry than
having a lingering updated draft guidance.
Answer 1. The content of this question is outside the scope of the
CIR mission. FDA, or members of the cosmetic industry, may provide the
information you are seeking.
Question 2. Dr. Bergfeld, you mention in your testimony that
members of the CIR Expert Panel are required to abide by conflict of
interest standards and, in addition, that the ingredient reviews and
safety assessments are transparent and available to the public. I've
long believed that, as long as there is a transparent conflict of
interest standard in place, having expert participation adds value and
allows decisions to be made in the real world, not an ideological void.
To that end, could you elaborate on how CIR's voting members review
available data and how products are reviewed annually on a priority
scale?
Answer 2. The Panel assesses the ingredient safety based on use in
cosmetics (i.e., concentration of use as well as types of exposure).
After reviewing the use data, the Panel considers safety using
information on some or all of the following criteria, as deemed
appropriate: composition and impurities data, dermal penetration data,
toxicokinetics studies, single and repeated dose studies (taking into
consideration the route of exposure that is applicable), developmental
and reproductive toxicity data, genotoxicity data, carcinogenicity
data, dermal irritation and sensitization data. If additional types of
data are needed to assess safety, the Panel will request those data;
the data request and the rationale for the additional need is made
publicly available.
CIR reviews acute, short-term, and chronic toxicity studies
performed in vivo on mammalian test species, in vitro studies using
animal or human cells and tissues, and epidemiological studies to
assess the potential for ingredients to cause any possible adverse
health effects. These effects include dermal, ocular, and mucous-
membrane irritation, sensitization (allergies), and phototoxicity after
short-term or long-term exposures. The effects also include
genotoxicity, cancers, reproductive and developmental effects, and
endocrine effects. As well, the Panel reviews studies of the potential
for neurotoxicity, immunotoxicity and other endpoints, as relevant and
appropriate for assessing the safety of ingredients, as used in
cosmetics.
Initially, CIR identified ingredients for review by known
biological activity or by stakeholder request. Once the review of that
list of ingredients thought to have a significant biological activity
began to decline significantly in number, CIR began to supplement each
year's agenda with selected ingredients based on frequency of use. Each
year, CIR develops a priority list of ingredients that are recommended
for review. This list is available for public comment and discussed in
open Expert Panel meetings multiple times before it is finalized by the
Expert Panel. There are three primary criteria for adding an ingredient
to the annual CIR Priority List.
1. The first is ``for cause.'' Ingredients may be nominated for
inclusion for specific concerns from multiple sources. Requests
may be made by stakeholders, such as the FDA, Members of
Congress, consumer groups, members of industry, members of the
CIR staff, members of the CIR Expert Panel, and members of the
general public.
2. The second criterion is the frequency of use (FOU) of
ingredients not previously reviewed by CIR. The process of
selecting ingredients based on how many products an ingredient
is used in, according to the FDA Voluntary Cosmetic
Registration Program (VCRP). Higher FOU ingredients get higher
priority.
3. The third criterion that may invoke a safety assessment by
the CIR Expert Panel is ``Re-review.'' A re-review or re-
assessment of the safety of ingredients or a family of
ingredients previously reviewed by CIR may be triggered either
by a request, as above, or the aging of the previous review to
15 years (i.e., CIR reviews the safety again to see if new data
or information would change their original conclusion.
In addition, ingredients that meet one of the criteria above may be
grouped with other ingredients in a report, where appropriate. Those
potential groupings are presented to the CIR Expert Panel, along with
those ingredients that meet one of the above criteria, during the
priorities setting process for approval.
Question 3. Dr. Bergfeld, can you elaborate on CIR's process when
there is not enough data or literature to make a safety determination
for an ingredient, and instead the ingredient is found to have
insufficient data to determine safety? What happens next? Are there
opportunities to submit more data or does the ingredient's safety
status ever change?
Answer 3. The CIR safety assessment process allows for numerous
opportunities for all interested parties to submit data for inclusion
in the report. During the initial report development process, industry
and all other interested parties are given several opportunities to
submit the requested data, most specifically through the issuance of an
Insufficient Data Announcement (IDA) that lists all the needed data.
The rational for the data request is also included in the Discussion
section of the Tentative Report. If the requested data have not been
submitted when the report is made final, interested parties are given 2
years to submit the needed data; if those data are not received in the
2 years following issuance of the final report, the following re-
categorization occurs:
i. If the ingredient is listed as in use according to the FDA
VCRP database, the conclusion is changed from ``insufficient
data,'' and it is classified as ``Use Not Supported by the Data
and Information Submitted to the CIR.''
ii. If the ingredient does not have any uses reported in the
VCRP database, it will be classified as ``No Reported Use.''
When an ingredient is found insufficient (and eventually classified
as Use Not Supported or No Reported Use), the conclusion remains as
such unless CIR is asked to reconsider the conclusion and the needed
data are made available. An interested party can petition the CIR at
any time to request the consideration of additional data, or to request
the Panel reconsider an existing conclusion.
senator murphy
Question. Do you think Federal cosmetic safety legislation should
specifically direct cosmetic manufacturers to substantiate the safety
of cosmetic chemicals for chronic health effects, including endocrine
disrupting properties as well as acute reactions?
Answer. The content of this question is outside the scope of the
CIR mission. FDA, or members of the cosmetic industry, may provide the
information you are seeking.
senator warren
Cosmetic Ingredient Review (CIR) Review and Administration
Question 1a. Does the Personal Care Products Council (PCPC) provide
funding for the CIR?
Answer 1a. Yes, the overall funding of CIR is provided by PCPC. The
Council Board of Directors determines the budget and personnel limits
for the CIR and provides periodic review of CIR expenditures.
Question 1b. If so, what percent of the organization's total
funding comes from PCPC? What was the dollar amount provided by PCPC to
CIR for fiscal year 2016?
Answer 1b. All of the funding for CIR is provided by PCPC. However,
CIR has control over how the budget is allocated and the projects
undertaken. The CIR operating budget for 2016 is $2,575,000.
Question 1c. What other organizations provide funding for the CIR?
What was the dollar amount provided to CIR for fiscal year 2016 by each
organization?
Answer 1c. CIR does not receive funding from any additional source.
Question 1d. Are any or part of CIR panel members' and staff's fees
or salaries paid by PCPC?
Answer 1d. Members of the Expert Panel and liaison representatives
may receive an honorarium and be reimbursed for their travel expenses
and all other out-of-pocket expenses, unless such compensation and
reimbursement is waived. The fees and expenses are included in the CIR
budget. The salaries for CIR staff are paid by PCPC. It's important to
note that CIR Panel members must meet the same conflict of interest
requirements regarding financial interests as special non-government
advisory experts to FDA.
Question 1e. If so, what percent of panel members' and staff's fees
salaries are paid by PCPC?
Answer 1e. Expert Panel members and liaison representatives are not
salaried employees of CIR. They are appointed, in part, based on their
scientific competence and expertise in an area relevant to the CIR. The
members include physicians, professors, department chairs and chairs of
professional associations such as the Society of Toxicology. Salaries
are paid by their employers. The honorarium and expenses that members
receive from CIR for participation in the Expert Panel meetings are
likely to be far less than what they receive from their employer or
what they could command as a consultant. CIR Panel members must meet
the same conflict of interest requirements regarding financial
interests as special non-government advisory experts to FDA.
CIR staff are considered to be employees of, or consultants to,
PCPC for the purposes of managing the payment of salaries and benefits
(i.e., CIR does not have their own accountant or human resources
director). CIR staff fees are 100 percent covered by PCPC. However, CIR
staff are substantively separate and independent from the PCPC staff
and management (i.e., day-to-day work, management, and all technical
and scientific matters are in no way directed by PCPC staff). The CIR
Director, alone, shall hire and direct the activities of the CIR staff
in order to implement the procedures (http://www.cir-safety.org/sites/
default/files/pdf1.pdf) effectively and efficiently. The Director shall
report to and be subject to the direction and control of the CIR
Steering Committee. No person on the CIR staff may serve on the PCPC
staff, and contacts between the CIR staff and Council staff are kept to
a minimum.
Question 1f. What are the average annual fees paid to CIR panel
members?
Answer 1f. The total average annual expenditure for the honorarium
and travel for the Expert Panel members (9 voting members) is
$355,000.00. Expenses for the consumer representative are also paid
from that average annual expenditure. No honorarium or expenses are
paid for the FDA or the Industry representative.
Question 1g. How is the CIR director appointed? What role does
PCPC, or its internal steering committee, play in appointing the CIR
director?
Answer 1g. The CIR Steering Committee provides the general policy
and direction for the CIR. Committee members include representatives
nominated by professional societies such as the American Academy of
Dermatology and the Society of Toxicology, the Consumer Federation of
America and industry. The Director of CIR is appointed by the Chair of
the Steering Committee, with the approval of the Chair of the PCPC
Board of Directors and the Chair of the Council Scientific Advisory
Committee Executive Committee. The CIR Director has the authority and
responsibility for daily administration of the CIR staff and the Expert
Panel.
Question 1h. How is the CIR expert panel chair selected? What role
does PCPC, or its internal steering committee, play in appointing the
CIR expert panel chair?
Answer 1h. The CIR Steering Committee selects the Chair of the
Expert Panel from among the Expert Panel members. Expert Panel members
are selected from those nominations that are the result of a public
call for nominations from any interested individual as well as from
consumer, industry, and professional organizations. The CIR Steering
Committee appoints these panel members after consultation with the
Consumer Liaison Representative and the FDA Liaison Representative.
Question 1i. How is the list of ingredients to be reviewed by the
CIR created each year? What role does PCPC, its internal steering
committee, or individual companies in the cosmetics industry play in
developing this list?
Answer 1i. Initially, CIR identified ingredients for review by
known biological activity or by stakeholder request. Once the review of
that list of ingredients thought to have a significant biological
activity began to decline significantly in number, CIR began to
supplement each year's agenda with selected ingredients based on
frequency of use. Each year, CIR develops a priority list of
ingredients that are recommended for review. This list is available for
public comment and discussed in open Expert Panel meetings multiple
times before it is finalized by the Expert Panel. There are three
primary criteria for adding an ingredient to the annual CIR Priority
List.
A. The first is ``for cause.'' Ingredients may be nominated for
inclusion for specific concerns from multiple sources. Requests
may be made by stakeholders, such as the FDA, Members of
Congress, consumer groups, members of industry, members of the
CIR staff, members of the CIR Expert Panel, and members of the
general public.
B. The second criterion is the frequency of use (FOU) of
ingredients not previously reviewed by CIR. The process of
selecting ingredients based on how many products an ingredient
is used in, according to the FDA Voluntary Cosmetic
Registration Program (VCRP). Higher FOU ingredients get higher
priority.
C. The third criterion that may invoke a safety assessment by
the CIR Expert Panel is ``Re-review.'' A re-review or re-
assessment of the safety of ingredients or a family of
ingredients previously reviewed by CIR may be triggered either
by a request, as above, or the aging of the previous review to
15 years (i.e., CIR reviews the safety again to see if new data
or information would change their original conclusion.
In addition, ingredients that meet one of the criteria above may be
grouped with other ingredients in a report, where appropriate. Those
potential groupings are presented to the CIR Expert Panel, along with
those ingredients that meet one of the above criteria, during the
priorities setting process for approval.
CIR Ingredient Assessments
Question 2a. In the event CIR identifies an acute health risk from
an ingredient, what specific actions are the agency empowered to take?
Answer 2a. The CIR is a scientific review organization that
considers all scientific information in the preparation of safety
assessments. If CIR identifies or is made aware of acute health risks
from an ingredient, CIR may bring the information to the attention of
FDA and to the Expert Panel. The FDA may recommend or the Expert Panel
may independently recommend placing the issue as a high priority for a
safety assessment.
Question 2b. Does CIR also take longer term health and safety risks
(e.g., cancer, lung disease, etc.) into account when assessing
ingredients?
Answer 2b. Yes, CIR does evaluate the potential long-term or
chronic health effects of ingredients as used in personal care
products.
As noted in the response to Representative Murray's questions, the
CIR Expert Panel bases its safety assessments on a comprehensive search
and review of the scientific literature and data submitted by
stakeholders to address all exposure scenarios applicable to the
consumer use of cosmetics (comprising all relevant types of personal
care products) and potential toxicity endpoints (i.e., adverse health
effects). The scenarios considered include long-term exposures to an
ingredient at maximum reported concentrations in personal care products
used as often as multiple times a day.
The potential adverse health effects considered by the Panel
include the full range of possible toxicity endpoints, including
potential carcinogenic effects after long-term exposures and the
potential for irritation of the respiratory tract and induction of
allergic sensitization after incidental inhalation exposures (long-term
and short-term) to ingredients in spray and loose-powder cosmetic
products.
A ``safe as used'' conclusion by the Panel for an ingredient
indicates a negligible risk of acute and chronic health effects after
long-term, daily exposures to the ingredient at its greatest reported
concentrations in cosmetic products, when these products are used as
intended.
Question 2c. Does CIR have the power to force a company to withdraw
an unsafe product or to change the product if acute health risks are
identified for the product?
Answer 2c. CIR does not have any regulatory authority to force a
company to withdraw an unsafe product or to change a product if acute
health risks are identified.
Question 2d. In the event CIR identifies a chronic health risk from
an ingredient, what actions is the agency empowered to take?
Answer 2d. CIR is not empowered to take any regulatory actions if a
chronic health risk from an ingredient is identified. However, the CIR
may notify FDA and Industry of their specific concerns and recommend
that appropriate investigation and action be taken to address the risk.
Question 2e. Does CIR have the power to force a company to withdraw
an unsafe product or to change the product if chronic health risks are
identified for the product?
Answer 2e. CIR does not have any regulatory authority to force a
company to withdraw an unsafe product or to change the product if
chronic health risks are identified for the product.
Question 2f. How many ingredient assessments has CIR conducted from
2010-Present?
Answer 2f. Prior to 2010, CIR safety assessments reports consisted
of individual ingredients or groups that contained a relatively small
number of ingredients. In 2009, significant process improvements
provided CIR with additional tools to improve efficiency. Currently,
CIR conducts safety assessments in a number of ways. In some instances,
a safety assessment is performed on a single ingredient. In other
cases, safety assessments are performed on a group of ingredients. Some
of those grouped assessments are initially prepared because of the
potential for read-across, where the data from one or more ingredients
may be useful to interpolate or extrapolate to a specific data gap for
another ingredient in the group. Read-across is not possible for all
types of chemicals, such as inorganic chemicals or botanical
ingredients; but, there is often value added by reviewing the
ingredients together in a group, as compared to individually (e.g.,
evaluating the significance of a constituent of concern shared in
common in a group of botanical ingredients, saves effort, time, and
money, with absolutely no loss in the scientific rigor by which those
ingredients are reviewed). Whether an ingredient is assessed in a
report all by itself, or assessed in a report with 50 other
ingredients, there is no less rigor in the investigation of the safety
of an ingredient. The same types of searches are performed; the same
data endpoints are sought; and, the same analyses are performed.
Assessing the safety of ingredients in a group, as opposed to assessing
the safety of an ingredient individually, adds value to the review
process.
Additionally, in any given year, a re-review or re-assessment of
the safety of ingredients or a family of ingredients previously
reviewed by CIR may be triggered either by a request, or the aging of
the previous review to 15 years (i.e., CIR reviews the safety again to
see if new data or information would change their original conclusion).
However, ingredients may be re-reviewed sooner for cause (e.g.,
requested by a stakeholder) or if their re-review with a group of
previously unreviewed ingredients may be informative to some part of
the safety assessment process. Thus for any given year, the CIR
workload may consist of individual ingredients that have not been
previously reviewed by the Panel, individual ingredients that have been
reviewed and are candidates for the 15-year re-review cycle, and groups
or ``families'' of similar ingredients that may contain ingredients
that have not been reviewed and those that have been previously
reviewed. Added to this complexity is the potential for some
ingredients to receive split, or multi-part conclusions.
Therefore, including all of the ways above that ingredients may be
included for review or re-review, CIR assessed the safety of
approximately 3,713 ingredients from 2010 through September 2016 (some
of which were previously reviewed by the Expert Panel, and re-reviewed
in this 6-year time span). These ingredients were assessed in 130
reports, most of which comprise multiple ingredients that constitute
ingredient ``families.''
Question 2g. In how many cases has CIR deemed an ingredient unsafe
or conditionally unsafe (e.g., dose-dependence, exposure limits, etc.)
during this time period?
Answer 2g. Since 2010, 4 ingredients have been found conditionally
unsafe. A total of 12 ingredients have unsafe conclusions; of those, 7
ingredients have been found unsafe and 5 (including the 4 above) have
been found conditionally unsafe.
Question 2h. Please provide a list of each ingredient that has been
deemed unsafe or conditionally unsafe, and the reason they were found
to be unsafe or conditionally unsafe.
Answer 2h. A total of 12 ingredients have been found unsafe; 5 of
these 12 have mixed conclusions.
A. Unsafe:
i. 4-Methoxy-m-Phenylenediamine--the Panel agreed with the
IARC listing of ``possibly carcinogenic to humans.'' [JACT
11(4) 1992]
ii. 4-Methoxy-m-Phenylenediamine HCl--as above.
iii. 4-Methoxy-m-Phenylenediamine Sulfate--as above.
iv. Chloroacetamide--potential human sensitizer at
concentrations used in cosmetics. [JACT 10(1) 1991]
v. Ethoxyethanol--reproductive and developmental toxicity
associated with dermal and other exposure. [IJT 21S1) 2002]
vi. Ethoxyethanol Acetate--as above.
vii. HC Blue No. 1--unsafe for use in cosmetic formulations
until further information elucidating the carcinogenic
potential by dermal application at the maximum tolerated dose
is available. [JACT 13(5) 1994]
B. Conditionally Unsafe:
viii. Formaldehyde--unsafe in hair-smoothing (aka hair-
straightening) products because of concerns of sensory
irritation due to formaldehyde vapor formation with the
application of heat to these types of products and concerns of
inadequate ventilation with use:
aa. Safe for use when formulated to ensure use at the
minimal effective concentration, but in no case should the
formalin concentration exceed 0.2 percent (w/w)., which would
be 0.074 percent (w/w) calculated as formaldehyde or 0.118
percent (w/w) when calculated as methylene glycol.
bb. Safe as used in nail-hardening products. [IJT 32(S4)
2013]
ix. Methylene Glycol Formaldehyde--same as that for
formaldehyde.
x. Hydroquinone--unsafe for use in leave-on cosmetic
cosmetics except nail adhesives and artificial nail coatings
due to the potential to cause depigmentation:
aa. Safe for use in nail adhesives and in artificial nail
coatings, as a polymerization inhibitor, that are cured by LED
light.
bb. Safe at concentrations of 1 percent in rinse-off
products. [Dec 2014 Panel meeting]
xi. p-Hydroxyanisole--unsafe for use in all cosmetics except
nail adhesives and artificial nail coatings due to dermal
depigmentation potential:
aa. Safe for use in nail adhesives and in artificial nail
coatings, as a polymerization inhibitor, that are cured by LED
light. [Dec 2014 Panel meeting]
bb. Pyrocatechol--unsafe for use in leave-on products due
to significant potential to act as a carcinogen and co-
carcinogen.
cc. Use Not Supported for use in hair dyes. [IJT 16(S1)
1997]
Question 2i. For each ingredients listed in (h), please provide a
description of all actions taken by CIR in response to the entity being
deemed unsafe or conditionally unsafe.
Answer 2i. CIR announces its finding after each meeting. All
ingredients determined to be unsafe are listed on the CIR Web site and
are listed in the annual compendium of ingredients. Additionally, the
CIR Director reports on the status of unsafe ingredients as part of the
Directors Report that is given at the last Expert Panel meeting of the
year.
Question 2j. When CIR performs an ingredient review, who is
responsible for compiling that data and deciding what studies make it
into the review? Is it the nine independent academics on the Expert
Panel, or the CIR staff?
Answer 2j. The CIR staff conducts the literature search, determines
the relevance (but not the credibility of the studies), and compiles
the data for review in a Scientific Literature Review (SLR) report that
is made publicly available for a 60-day comment period. Comments,
suggestions for additional related studies, and data received related
to the SLR and the scientific information in the original SLR are used
to develop a draft report for discussion at the Expert Panel meeting.
The Expert Panel evaluates the credibility of the data and will
comment if there are concerns for the reliability of the study. Other
stakeholders, such as those in academia or industry, are also welcome
to comment on the studies submitted in support of the review.
Question 2k. Are CIR recommendations informed primarily by
literature reviews? What other factors are considered when reviewing an
ingredient?
Answer 2k. A review of the published literature is the first step
in assessing safety; this information is often supplemented by the
submission to CIR of unpublished data or additional studies that may
have become available. CIR also reviews and includes in the assessment
relevant information from regulatory activities of other countries. The
Panel may also take into consideration observations from their clinical
experience and knowledge gained thru their involvement is other
scientific professional affiliations such as standards setting
organizations.
Question 2l. How much is your independent review limited by the
data the company in question chooses to provide you?
Answer 2l. CIR does not review ingredients or data based on
specific companies. Since the ingredient being reviewed may be used in
multiple products, CIR may review data submitted by multiple companies
that include the ingredient of interest in their product(s). If data
found in the published literature (and those submitted to CIR) are
insufficient to determine safety, and the industry as a whole does not
provide the additional data needed to conclude on the safety of an
ingredient, a conclusion of insufficient data will be issued.
Question 2m. Can CIR require cosmetic manufacturers to disclose
ingredients?
Answer 2m. The focus of the CIR safety assessment is on individual
ingredients that may be used in the manufacture of one or many personal
care products. CIR evaluates the safety of ingredients, as used in
cosmetic products; CIR does not evaluate the safety of final products
that may contain multiple ingredients. CIR has no regulatory authority
to require cosmetic manufacturers to disclose the ingredients in their
final products (but FDA does).
Question 2n. If a manufacturer does not voluntarily disclose an
ingredient, can CIR conduct a review? If so, under what circumstances?
Answer 2n. CIR assesses the safety of individual ingredient used in
cosmetics. The priority ingredients identified for CIR review are found
in the International Cosmetic Ingredient Dictionary and Handbook. CIR
does not assess the safety of a (finished) product, but reviews
individual ingredients as found in finished products. All information
on ingredients reviewed is provided to CIR voluntarily. After reviewing
the information submitted, the Expert Panel may request additional
scientific information from industry and the public. However, CIR does
not conduct a review of the manufacturer to obtain the information.
Question 2o. Are manufacturers required to report adverse events
associated with their products to CIR?
Answer 2o. CIR seeks information on adverse events associated with
ingredients used in cosmetic products from the literature, industry,
the public and from FDA. There is no regulatory requirement for
manufacturers to report adverse events associated with ingredients or
products to CIR.
Question 2p. Which specific products deemed unsafe by CIR have been
pulled from the market? What were the specific issues of concern?
Answer 2p. CIR does not have any regulatory authority to force a
company to withdraw an unsafe product from the market and CIR is not
empowered to take any regulatory actions if a health risk from an
ingredient is identified. However, the CIR may notify FDA and Industry
of their specific concerns and recommend that appropriate investigation
and action be taken to address the risk.
The Expert Panel found a total of 12 ingredients unsafe; 5 of these
12 have mixed conclusions.
A. Unsafe:
i. 4-Methoxy-m-Phenylenediamine--the Panel agreed with the
IARC listing of ``possibly carcinogenic to humans'' [JACT 11(4)
1992]
ii. 4-Methoxy-m-Phenylenediamine HCl--as above.
iii. 4-Methoxy-m-Phenylenediamine Sulfate--as above.
iv. Chloroacetamide--potential human sensitizer at
concentrations used in cosmetics. [JACT 10(1) 1991]
v. Ethoxyethanol--reproductive and developmental toxicity
associated with dermal and other exposure. [IJT 21S1) 2002]
vi. Ethoxyethanol Acetate--as above.
vii. HC Blue No. 1--unsafe for use in cosmetic formulations
until further information elucidating the carcinogenic
potential by dermal application at the maximum tolerated dose
is available. [JACT 13(5) 1994]
B. Conditionally Unsafe (mixed conclusions)
viii. Formaldehyde--unsafe in hair-smoothing (aka hair-
straightening) products because of concerns of sensory
irritation due to formaldehyde vapor formation with the
application of heat to these types of products and concerns of
inadequate ventilation with use.
aa. Safe for use when formulated to ensure use at the
minimal effective concentration, but in no case should the
formalin concentration exceed 0.2 percent (w/w)., which would
be 0.074 percent (w/w) calculated as formaldehyde or 0.118
percent (w/w) when calculated as methylene glycol.
bb. Safe as used in nail-hardening products. [IJT 32(S4)
2013]
ix. Methylene Glycol Formaldehyde--same as that for
formaldehyde.
x. Hydroquinone--unsafe for use in leave-on cosmetic cosmetics
except nail adhesives and artificial nail coatings due to the
potential to cause depigmentation.
aa. Safe for use in nail adhesives and in artificial nail
coatings, as a polymerization inhibitor, that are cured by LED
light.
bb. Safe at concentrations of 1 percent in rinse-off
products. [Dec 2014 Panel meeting]
xi. p-Hydroxyanisole--unsafe for use in all cosmetics except
nail adhesives and artificial nail coatings due to dermal
depigmentation potential.
aa. Safe for use in nail adhesives and in artificial nail
coatings, as a polymerization inhibitor, that are cured by LED
light. [Dec 2014 Panel meeting]
bb. Pyrocatechol--unsafe for use in leave-on products due
to significant potential to act as a carcinogen and co-
carcinogen.
cc. Use Not Supported for use in hair dyes. [IJT 16(S1)
1997]
Question 2q. For products listed in (o), how much time elapsed
between publishing the assessment and the product recall?
Answer 2q. CIR does not have any regulatory authority to force a
company to withdraw an unsafe product from the market. However, the CIR
may notify FDA and Industry of their specific concerns and recommend
that appropriate investigation and action be taken to address the risk.
FDA has stated that it does not have (mandatory) recall authority
for cosmetics and personal care products. They may seek voluntary
recall action from a company after communicating their safety concerns.
The FDA may communicate with industry (e.g., issue letters of concern
or Warning Letters) as a result of CIR Expert Panel determinations that
an ingredient was unsafe but CIR is not involved in the regulatory
actions of FDA.
Question 2r. If an ingredient is deemed conditionally unsafe, what
specific actions must industry take to inform consumers? What specific
actions do they voluntarily take? Please provide examples from 2010-
Present.
Answer 2r. The content of this question is outside the scope of the
CIR mission. FDA, or members of the cosmetic industry, may provide the
information you are seeking.
Safety Assessment
Question 3a. Does CIR assess individual ingredients in cosmetic
products, or assess products as a whole?
Answer 3a. CIR assesses the safety of individual ingredients, as
used in cosmetic products. Assessing the safety final cosmetic products
(containing multiple ingredients) is not feasible for CIR, both from a
scientific/technical perspective and a financial one. However, the CIR
Expert Panel evaluates the safety of individual ingredients under
conditions of use and formulation.
Question 3b. On what scientific and technical evidence does CIR use
to justify evaluating individual ingredients instead of complete
products?
Answer 3b. The CIR Expert Panel evaluates individual ingredients,
rather than finished products, because toxicity studies generally apply
to the toxic effects, dose-response relationships, mechanisms of
action, and exposures to individual ingredients, rather than mixtures,
such as cosmetic formulations. The evaluation of the safety and risks
associated with mixtures is a complex, new and emerging area, and CIR
is following developments in this area. CIR uses test data from studies
on cosmetic formulations and other mixtures whenever these data are
available to inform the assessment of the safety of individual
ingredients in cosmetic formations.
In addition, the CIR considers the types (categories) of cosmetic
products in which the ingredient is used and often provides guidance to
manufacturers for the use of an ingredient in cosmetic products, as
warranted to ensure safety. However, the complexities of evaluating the
safety of finished products, the time required, and data availability
make the cost of such assessments prohibitive.
Question 3c. What studies have shown that assessment of individual
ingredients is technically sound and reliable in ensuring safety, as
opposed to assessing complete products?
Answer 3c. See above for ``3b.''
Question 3d. When conducting assessments, does CIR review groups
that are structurally and/or mechanistically similar (called the
``read-across'' method), rather than individual chemicals?
Answer 3d. CIR conducts safety assessments in a number of ways. In
some instances, a safety assessment is performed on a single
ingredient. In other cases, safety assessments are performed on a group
of ingredients. Some of those grouped assessments are initially
prepared because of the potential for read-across. This is not to say
that data on any one ingredient in that group is not sought, but data,
once obtained, from one or more ingredients may be useful to
interpolate or extrapolate to a specific data gap for another
ingredient in the group. Potential read-across, however, is not the
only valid rationale for assessing the safety of ingredients as a
group. It is important to note that the rationale behind a structure
activity relationship and the rationale for grouping ingredients for
assessment need not be one and the same.
CIR will commonly review a group of inorganic ingredients in one
review, and also commonly review a group of botanical ingredients in
another review. Read-across is not possible for inorganic chemicals or
botanical ingredients; but, there is often value added by reviewing the
ingredients together in a group, as compared to individually (e.g.,
evaluating the significance of a constituent of concern shared in
common in a group of botanical ingredients, saves effort, time, and
money, with absolutely no loss in the scientific rigor by which those
ingredients are reviewed).
The key issue is that there is no less rigor in the investigation
of the safety of an ingredient, whether it is assessed in a report all
by itself, or assessed in a report with 50 other ingredients. The same
types of searches are performed; the same data endpoints are sought;
and, the same analyses are performed. Assessing the safety of
ingredients in a group, as opposed to assessing the safety of an
ingredient individually, adds value to the review process.
The conclusions of safety of ingredients in a group assessment do
not need to stand or fall together; the CIR Expert Panel routinely
issues split (or multi-part) conclusions wherein some ingredients may
be deemed ``safe as used,'' while others in the same report may be
deemed ``safe with limitations,'' and still others deemed ``use not
recommended.'' Differences, like similarities, can be substantively
informative in a safety assessment.
Question 3e. What is the scientific basis for using the method?
What studies or reviews from the literature indicate the method is safe
and reliable?
Answer 3e. The practice of predicting properties of chemicals is
established in regulatory science, and improved techniques are evolving
as scientific knowledge develops and is applied to this field.
Substances that have chemical and toxicological properties that are
likely to be similar, or that follow a regular pattern as a result of
structural similarity, may be considered for potential read-across, for
a specific endpoint. Commonly, a conservative (i.e. limits are set
lower than likely necessary to protect human health) margin of safety
is set when such methodologies are applied, to ensure against
uncertainties in interpolation or extrapolation of data.
Question 3f. What exact criteria does CIR use for (1) deciding if a
read-across approach is appropriate for a group and (2) systematic
methodology for conducting read-across assessments and evaluating their
validity?
Answer 3f. ``Read-across,'' as used by CIR, comprises a multitude
of approaches that are applied on a case-by-case basis. All such uses
of read-across utilize the CIR Expert Panel's expert judgment.
Here is one example: ingredients w, x, y, and z may be grouped
together in an assessment. The available data are collected on each
ingredient and presented to the Panel in a draft report. If there is a
specific data gap for ingredient y (e.g., no available data on whether
ingredient y irritates the skin at maximum reported cosmetic use
concentration), then the Panel may choose to interpolate specific data
from ingredients w, x, and z (e.g., that these ingredients do not cause
irritation at the maximum use concentration), if the Panel deems in
their expert judgment, that the data for w, x, and z are of high
quality and that the structural similarity (of w, x, and z to y) leads
to a reasonable expectation of chemical/toxicological similarity for
that endpoint (e.g., irritation).
The evaluation of both the quality of data, and the validity of
expected similarities between 2 or more chemicals is a rapidly
advancing field, of which the Panel routinely reappraises via hosted
workshops and presentations.
Question 3g. Aside from read-across, what other methodologies does
CIR use to assess safety? Enumerate the reasons why those methodologies
would be used over read-across and vice versa.
Answer 3g. Read-across is just one methodology that CIR uses to
assess safety. Primarily, CIR assesses the safety of cosmetic
ingredients based on classical toxicological methodologies and
experimental data. The types of data sought by CIR include:
Chemistry
Composition, Properties, Impurities, Methods of
Manufacture and Purification
Systemic Toxicity and Toxicokinetics (ADME)
Reproductive & Developmental Toxicity Studies
Genotoxicity
Carcinogenicity
Other Systemic Toxicity Endpoints (e.g.,
Neurotoxicity)
Local Effects
Dermal Toxicity
Irritation & Sensitization
Phototoxic Effects (including Photo-Allergenic
Effects)
Other Dermal Effects (e.g., drug effects,
depigmentation, comedogenicity)
Ocular Toxicity
Irritation & Other Ocular Effects (e.g., corneal
opacity, cataracts)
Mucous Membrane Toxicity
Irritation & Other Mucous Membrane Effects
Clinical Reports
Retrospective & Multicenter Studies
Case Reports
Other Relevant Clinical Studies (e.g.,
Pharmaceutical Testing, if relevant to safety)
Adverse Event Reports
Cosmetic and other Personal Care Products (e.g.,
US FDA CAERS)
Pharmaceutical Products (e.g., US FDA OpenAccess
DBs)
Epidemiological Studies
Cancer Endpoints
Non-Cancer Endpoints
Third Party Completed Quantitative Risk Assessments
(QRA) (e.g., from U.S. EPA, OSHA, NIOSH, NAC AEGL Committee,
ACGIH, WHO, SCCS, etc.)
Cancer Endpoints
Non-Cancer Endpoints
Only when a specific data point of the type above is unavailable
for an ingredient, does CIR consider approaches such as read-across,
and only for those endpoints. Other approaches comprise application of
the Framework for Identifying and Evaluating Analogs, Weight of
Evidence (WoE) evaluation, Threshold of Toxicological Concern (TTC)
assessment, and like, widely accepted approaches used worldwide by
safety assessors.
Question 3h. How does CIR currently determine if evaluating a
single ingredient of a product at a time will ensure consumer safety,
as opposed to evaluating the product as a whole?
Answer 3h. See above for ``b.''
Question 3i. How does CIR assess an ingredient's safety in
vulnerable populations, such as infants, children, pregnant women, and
salon workers?
Answer 3i. CIR considers vulnerable populations wherever
appropriate. CIR has looked extensively into the differences in
exposures among adults, children, and infants, especially comprising
the role of skin differences and the heightened importance of
developmental safety in children and infants. Indeed, CIR has hosted
workshops and topics such as infant skin penetration to be sure the
Panel has a state-of-the-art understanding of those specific issues.
As part of our routine safety data set, CIR assesses Reproductive &
Developmental Toxicity (DART) Studies. These studies are part of the
safety picture for both pregnant mothers, and the developing fetuses.
The Panel considers how such factors may impact this population.
Occupational safety, such as that for salon workers, is under the
regulatory authority of Occupational Safety and Health Administration
(OSHA). However, though not the regulatory authority of CIR, the Panel
will, when appropriate, consider and recommend conditions for safe use
under occupational use (e.g., CIR's report on Formaldehyde and
Methylene Glycol. (http://online.personalcare
council.org/ctfa-static/online/lists/cir-pdfs/PR582.pdf.).
Response by Scott Faber to Questions of Senator Murray, Senator Enzi,
Senator Hatch, and Senator Baldwin
senator murray
Question 1. In July, FDA announced it had received 127 adverse
event reports about WEN hair products through its voluntary reporting
system for consumers and clinicians. After further investigation, FDA
found that the maker of WEN had actually received more than 21,000
consumer complaints about the product--but under current law, the
company did not have to report these to the FDA.
How do companies distinguish between consumer complaints and
adverse event reports, and do you believe that most companies report
adverse events to the FDA?
What assurances do consumers have that all companies are
classifying adverse events correctly and reporting them to the FDA?
Answer 1. Cosmetics companies are not required to report adverse
events. While adverse events are defined by rule for other FDA-
regulated products, adverse events are not defined for cosmetics. As a
result, companies are not required to distinguish between routine
consumer complaints and adverse events. Although companies, doctors,
and consumers can voluntarily report adverse events, FDA does not
provide guidance to distinguish between consumer complaints and adverse
events. The Personal Care Products Council's Consumer Commitment Code
advises companies to report ``serious'' and ``unexpected'' adverse
events, as defined by FDA for drugs, but this Code is not legally
binding. As a result, consumers have no assurance that companies are
properly identifying adverse events, and FDA is unable to detect and
respond to products that may pose short-term health risks.
Question 2. Many companies in the cosmetic industry and consumer
groups have their own lists of ``safe'' and ``unsafe'' ingredients.
What standards do you use to create these lists for the organizations
you represent?
Answser 2. EWG has developed a standard for products that can carry
our EWG VERIFIEDTM seal. Our standard prohibits the use of certain
chemicals and mandates that other chemicals of concern meet the
restrictions set by authoritative bodies. Products must also receive a
``green'' score from EWG's Skin Deep rating system, fully disclose all
ingredients on the label (including fragrance ingredients), and must
implement good manufacturing practices to reduce the risk of
contamination. For more details, visit: http://www.ewg.org/
ewgverified/.
Question 3a. FDA can only request a voluntary recall of a cosmetic
if it is misbranded or adulterated. Recently, there was a great deal of
press about WEN cleansing conditioner products that caused hair loss in
consumers, many of them children. Does the ``misbranded or
adulterated'' standard allow FDA to recall products that cause
consumers severe harm, like hair loss in this case?
Answer 3a. Under current law, an ``adulterated'' product is
generally understood to be a product that is contaminated. In some
cases, a chemical is so dangerous that FDA has concluded that the
chemical is ``injurious to health'' and prohibits its use. However,
none of the chemicals used in WEN have been banned by FDA, and the
agency has not concluded that WEN is ``adulterated.'' What's more, FDA
has not reviewed any of the chemicals used in WEN for safety, including
preservatives that have been restricted by other authoritative bodies.
Even if FDA concluded that a product was ``adulterated,'' FDA cannot
order a mandatory recall.
Question 3b. What additional authority does FDA need to make sure
products that cause consumers harm are expeditiously removed from
shelves?
Answer 3b. In order to assess the safety of products like WEN, FDA
should have the power to identify, review and (if warranted) regulate
cosmetics chemicals of concern through a label warning, restriction, or
ban. In order to identify chemicals for review and regulation, FDA must
have sufficient information about chemical use and toxicity. If a
product poses the risk of serious adverse health consequences or death,
and the manufacturer has not initiated a voluntary recall, FDA should
have the power to order a mandatory recall.
Question 3c. Has the cosmetics industry's self-regulatory system
been able to remove products like WEN from the market when there is
concern about consumer harm?
Answer 3c. While industry self-regulatory programs can supplement
FDA chemical reviews, industry self-regulatory programs lack basic
information about chemical use and exposure. In some cases, industry
review programs and governmental authorities have reached different
conclusions about chemical safety. While some chemicals have been
``banned'' by self-regulatory programs like the Cosmetic Ingredient
Review program, these findings do not have the force of law. In
addition, the industry's self-regulatory program is not designed to
detect products that may pose serious health consequences and does not
have the power to order a recall if a manufacturer has declined to
voluntarily remove contaminated products from the market.
Question 4a. Many consumers and families are rightly concerned
about the long-term health effects of exposure to very low doses of
cosmetic ingredients from the products that they use each day, year
after year. What studies need to be done to answer consumers and
families' questions about long-term health effects, like endocrine
disrupting effects, of cosmetic ingredients?
Answer 4a. The National Academy of Sciences issued three reports
between 2007 and 2009 that recommended modernizing chemical health
evaluations, including toxicity testing and chemical risk evaluation.
These reports identify the studies and other methods agencies like FDA
should employ to identify and fill data gaps, to assess the cumulative
impacts of chemicals, to assess the impacts of low doses of chemicals,
and to consider the vulnerability of certain populations, such as
pregnant women and children. For more information, visit: http://
dels.nas.edu/resources/static-assets/materials-based-on-reports/
reports-in-brief/IRA_brief_final
.pdf and http://dels.nas.edu/resources/static-assets/materials-based-
on-reports/reports-in-brief/Toxicity_Testing_final.pdf.
Question 4b. Are those the type of studies that CIR reviews when
determining whether an ingredient is safe?
Answer 4b. In general, self-regulatory panels review published
studies of the short-term effects of cosmetics chemicals, such as
allergic reactions, and tend to overlook chronic effects of cosmetics
chemicals, including chemicals that impact the endocrine system. Self-
regulatory panels do not tend to rely on studies that assess the long-
term impacts of repeated chemical exposures.
Question 4c. Please explain the discrepancy between conclusions
reached by regulators in Europe and those reached by CIR in the
interpretation of available scientific data about whether certain
ingredients are safe for use.
Answer 4c. Unlike self-regulatory panels, government authorities
assess the long-term impacts of repeated chemical exposures. In
addition, governmental authorities have tools needed to fill data gaps
(such as requiring additional studies) and accurately measure aggregate
exposure through ingredient statements and use reporting.
Question 5. Products such as the ``Brazilian Blowout'' remain on
the market despite the fact that CIR and the FDA found that the
formaldehyde content was unsafe. Why and how are companies still
marketing products even after CIR and the FDA found formaldehyde to be
unsafe?
Answer 5. Although FDA has limited authority to ban or restrict
cosmetics chemicals, EWG believes that a known carcinogen like
formaldehyde in hair straighteners is clearly ``injurious to health''
and should not be permitted in personal care products. To view our
petition to FDA, click here: https://www.regulations.gov/docket?D=FDA-
2011-P-0276. If FDA fails to act on our petition, formaldehyde and
formaldehyde-releasing chemicals should be among the first chemicals
reviewed and regulated by FDA.
Question 6a. Some businesses single-source their ingredients,
formulations, and manufacturing facilities to control the quality of
the product and ensure that there is no cross-contamination by
potential allergens or other ingredients. I understand, however, that
this is not the norm in the industry. Please explain the supply chain
that cosmetics ingredients and finished products move through.
Question 6b. How do external formulators and manufacturers work
together with cosmetic and personal care product companies to inform a
final product?
Question 6c. What safeguards do companies employ to ensure that
products do not become contaminated with allergens from other products?
Question 6d. How do companies test for allergenicity in their final
products?
Answer 6a through 6d. In general, cosmetics formulators establish
manufacturing standards which suppliers must meet as a condition of
sale. These standards address a wide variety of factors, including raw
ingredient safety. Many formulators directly audit their suppliers and
rely upon qualified third parties to audit their suppliers. During this
process, formulators will require information on raw materials,
including safety data and safety certifications, and safety data
typically includes data on toxicity to human health and the
environment. In general, formulators take steps to avoid known
allergens during product formulation, and some companies test final
products and retain samples.
Question 7a. Some products like hair straighteners, and gel and
acrylic nail products, are used on consumers by a professional. Some of
these contain harsh chemicals--and present a unique risk to the
professional who is being continuously exposed to the product, as was
highlighted by a New York Times investigation into the safety of nail
salons. What are some of the long term health consequences of handling
some of these professional products every day, and what is being done
by the manufacturers to protect workers?
7Answer 7a. Nail salon workers are exposed to potentially toxic
chemicals in nail polishes, glues, and acrylic nails. Exposures to
these chemicals have been linked to asthma, miscarriages and other
reproductive issues, endocrine disruption, nervous system damage, liver
and kidney damage, and some cancers. In particular, workers are at risk
of long-term exposure to formaldehyde used in hair-straightening
products. Workers are also vulnerable to skin conditions like
dermatitis.
Methacrylate compounds in artificial nails can also cause
allergies, asthma, and dermatitis. In general, salon workers have few
protections. Although OSHA has set Permissible Exposure Levels for some
cosmetics chemicals, those levels are inadequate and outdated.
Question 7b. When formulating products meant for use by a
professional, do companies consider how these chemicals may impact the
long-term health of those handling them every day at work?
Answer 7b. Manufacturers are not required to consider worker
exposures when formulating products and I am not aware of companies who
take worker exposures into consideration.
senator enzi
Question 1. The Personal Product Safety Act includes packers and
holders in its definition of a "facility" which has raised concerns
about the fee payment obligations. Please provide specific examples of
cosmetic products which have become contaminated while in transit,
under the authority of a packer or a holder, or a contract
manufacturer.
What safeguards could be put in place to ensure that packers,
holders, and contract manufacturers, are not paying fees that have
already been paid by manufacturers?
Answer 1. I am not aware of examples of cosmetic products that have
been contaminated while in transit, but companies would not be required
to report instances of contamination to FDA. Unlike other product
categories, FDA does not have the authority to inspect company records
for cosmetic products, including records related to contamination in
transit.
Question 2a. There was no discussion during the hearing about how
the Personal Care Product Safety Act would affect the cost of insurance
for the cosmetic industry. How do the insurance premiums of cosmetic
companies compare to other FDA regulated product categories?
Answer 2a. Cosmetics manufacturers obtain insurance to cover a
variety of different losses, including product liability insurance. In
general, cosmetics manufacturer insurance policies cover losses caused
by contamination and other acute risks. By contrast, manufacturers of
other FDA regulated products tend to obtain insurance to cover losses
caused by chronic risks as well as losses caused by acute risks.
Question 2b. What is the average premium for a cosmetic company
which has gross annual domestic sales of $100,000?
Question 2c. What is the average premium for a cosmetic company
which has gross annual domestic sales of $500,000?
Answer 2b and 2c. The cost of cosmetics insurance premiums will
vary greatly. Factors include the scope and type of coverage, the type
of products, and the loss history of the manufacturer. However, small
manufacturers tend to pay less than $5,000 in annual insurance
premiums.
Question 3a. The Personal Care Product Safety Act mandates
registration with the Food and Drug Administration (FDA) of all
facilities which engage in manufacturing or processing of a cosmetic
product or a cosmetic formulation distributed in the United States. The
act excludes in its definition of a ``facility'' those domestic
cosmetic manufacturers who had less than $100,000 in gross annual sales
of cosmetic products. Is the $100,000 gross annual sales threshold an
adequate standard for the definition of a ``facility?''
Answer 3a. Companies with significant sales of personal care
products should be required to register with FDA, submit cosmetics
ingredient statements, and report adverse events. Without this
information, FDA would be unable to detect and respond when
contaminated products threaten consumers. Furthermore, FDA would lack
the information needed about chemical use to accurately estimate
chemical exposure.
Question 3b. What specific industries have expressed concern over
the $100,000 threshold in the definition of ``facility?''
3b. The fee structure included in S. 1014 is supported by the
Personal Care Products Council and by many large and small cosmetics
companies.
Question 3c. Have any specific industries advocated for a higher
annual sales threshold in the definition?
Answer 3c. To my knowledge, some handmade soap companies have
sought a higher threshold. However, true soaps that do not make
cosmetic or drug claims are not regulated as cosmetics and would not be
subject to S. 1014.
senator hatch
Question. FDA has a draft guidance on cosmetic good manufacturing
practices, which they initially published in 1997 and have revised
twice since then, once in April 2008 and again more recently in June
2013. If FDA were to finalize this guidance, or require manufacturers
to comply through rulemaking, how would it provide greater clarity for
the full range of manufacturers regarding best practices for
manufacturing safe cosmetic and personal care products? If the FDA is
updating its thinking in its regulatory capacity, I would think that
finalizing guidance provides more certainty for the industry than
having a lingering updated draft guidance.
Answer. EWG supports FDA efforts to finalize a draft guidance on
cosmetics manufacturing practices. Furthermore, we support provisions
of S. 1014 which require the establishment of cosmetics GMPs by rule
within 3 years of enactment.
senator baldwin
Question. Approximately 40 percent of all personal care products
include fragrances. Yet, fragrance suppliers and manufacturers
generally don't share information on fragrance ingredients, which makes
it incredibly difficult for manufacturers and consumers to fully assess
the safety of their products. Under the Personal Care Products Safety
Act (S. 1014), fragrance and flavors would be exempt from FDA
ingredient disclosure. What do we know about the health impacts--
including potential harmful effects--of fragrance ingredients, and how
can we ensure that manufacturers and consumers have access to this
information?
Answer S. 1014 does not provide full fragrance ingredient
disclosure or meet the ingredient disclosure standards required by the
European Union. However, S. 1014 does increase fragrance ingredient
disclosure when compared to current law in two respects. First,
fragrance companies must provide all fragrance ingredient information
to FDA following an FDA request to do so. Second, companies are
required to provide, through a phone number, product-by-product
fragrance ingredient information to consumers.
Response by Curran Dandurand to Questions of Senator Alexander, Senator
Murray, Senator Enzi, Senator Hatch, and Senator Baldwin
senator alexander
Question 1. You stated in your testimony that your company, Jack
Black, LLC, now includes about 50 products that are marketed in all 50
States. What considerations do you take into account when choosing the
various ingredients to include in your products?
Answer 1. We look at a number of things, including regulatory
requirements in the markets where the product will be sold, who is the
product designed for (factors such as customer's skin type, hair type
or the particular skin or hair concerns the product is intended to
address), what are the intended benefits and functions of the product,
what are the desired aesthetics (viscosity, texture, aroma, product
form) and what claims do we want to make for the product. In addition,
we have a list of ``prohibited ingredients'' that we give to our
formulators as part of the Product Profile that formally initiates new
product development projects, this list is regularly updated and is
based on a variety of United States and international databases, safety
and toxicology consultants input, and takes into account U.S. State and
global regulations as well as public opinion of various ingredients.
Question 2a. You stated in your testimony that there should be
``one consistent National Standard'' for cosmetics, at least in part
because ``there has been a movement to create separate state
requirements,'' compliance with which may be ``burdensome and
impossible for small companies like ours.'' To what extent do you
believe that new national requirements for cosmetics manufacturers
should operate to eliminate additional or different State requirements?
Answer 2a. This is very important not only for industry, but for
consumer confidence and ensuring clarity and clear communications to
the public about the safety of our industry's products and ingredients.
One National Standard gives more confidence and certainty to all
constituencies and helps eliminate confusion and anxiety about what is
safe and what is not safe. If the National Standard is developed based
on extensive, peer reviewed safety and toxicology studies compiled from
experts worldwide indicating that a given ingredient is safe for use at
specific levels, then individual States should not be allowed to impose
separate laws that are contradictory to the National Standard. This
should also include labelling and any warning statements required on
packaging, where one National Standard should be used to govern
practices in all 50 States.
Question 2b. To what extent do you believe it is feasible for small
companies like yours to comply with both a uniform national standard
and additional or different State requirements?
Answer 2b. It would not be feasible and would be very burdensome
for small companies to have to comply with both a National Standard as
well as potentially 50 different diverse State standards. The cost of
doing business would dramatically increase, both in overhead costs to
maintain a regulatory staff to monitor and ensure compliance, plus
there would be an increase in the cost of the product itself due to
having to produce very small runs to accommodate individual State
requirements. Most small companies, particularly startups, struggle to
meet contract manufacturers' and component suppliers' minimums anyway,
so layering on a lot of very small separate runs for different States
would make it very challenging if not impossible to build a profitable
business.
Question 3. Dr. Bergfeld testified that when CIR reviews an
ingredient or group of ingredients, it issues a finding of safe, safe
for use with certain restrictions, unsafe for use in cosmetics, or
lacking sufficient data to determine safety. How does a company account
for each of these four types of safety findings when working to
formulate new or continuing to develop personal care products?
Answer 3. I can't speak to how other companies use these findings
in their formulation development work, but we use safety and toxicology
consultants, who specialize in cosmetics and personal care products, to
review all ingredients we are considering using in a formula. They take
into account CIR findings as well as other available data and would
advise us not to use ingredients that were not substantiated for
safety.
senator murray
Question 1a. In July, FDA announced it had received 127 adverse
event reports about WEN hair products through its voluntary reporting
system for consumers and clinicians. After further investigation, FDA
found that the maker of WEN had actually received more than 21,000
consumer complaints about the product--but under current law, the
company did not have to report these to the FDA. How do companies
distinguish between consumer complaints and adverse event reports, and
do you believe that most companies report adverse events to the FDA?
Answer 1a. I am not able to answer what most companies do when it
comes to reporting adverse events, perhaps someone at FDA has more data
about that, but we consider an adverse event to be something that is
serious and unexpected and/or causes the customer to go to the doctor
or hospital.
Question 1b. What assurances do consumers have that all companies
are classifying adverse events correctly and reporting them to the FDA?
Answer 1b. Companies are supposed to report serious adverse events
to FDA for OTC products, and FDA has encouraged consumers to submit
adverse events to the agency directly.
Question 2. Many companies in the cosmetic industry and consumer
groups have their own lists of ``safe'' and ``unsafe'' ingredients.What
standards do you use to create these lists for the organizations you
represent?
Answer 2. We rely on safety and toxicology experts to guide us, we
reference international regulatory databases/websites, and we factor in
State and international regulations (see answer to Question 1 from
Chairman Alexander). We also monitor some of the various lists from
consumer groups (reputable ones backed by science) that are out there
regarding assessments of ingredients. (Note that there is a
proliferation of these type of safe/unsafe ingredient lists and anyone
can start their own list and post on the internet, so it is very
confusing to consumers to know which lists to trust. Many of the lists
are created by entities that disparage certain ingredients and use this
to create fear and as the basis for promoting their own products as
``non-toxic'').
Question 3a. Some businesses single-source their ingredients,
formulations, and manufacturing facilities to control the quality of
the product and ensure that there is no cross-contamination by
potential allergens or other ingredients. I understand, however, that
this is not the norm in the industry.
Answer 3a. I have heard of this in food (meat) production to
isolate sourcing from one animal, but am not aware of this being
practiced in our industry. I think this would be difficult to achieve
given the fact that one supplier usually isn't able to supply all the
various ingredients that are needed for most personal care products.
This question can be better answered by an expert in contract
manufacturing or a raw material supplier.
Question 3b. Please explain the supply chain that cosmetics
ingredients and finished products move through.
Answer 3b. The most detailed and thorough answer should come from
someone in contract manufacturing, they can explain the entire process
from sourcing the raw materials, supplier certification, receiving/
inspection to ascertain identity and quality of each raw material,
quality assurance, sampling, testing, batching, micro, filling, etc.
Question 3c. How do external formulators and manufacturers work
together with cosmetic and personal care product companies to inform a
final product?
Answer 3c. This response is from my perspective only, and I'm not
speaking for others in the industry as they may approach it
differently. The big companies have their own in house formulators and
manufacturing facilities. Smaller companies may use formulators that
are part of the contract manufacturers' team. As explained in my
previous answer, we start the process by developing a product profile
with all the specifications, such as who is the target consumer,
desired and prohibited ingredients, performance metrics, benefits,
aesthetics and claims spelled out. In addition, target costs, packaging
components, sizes and time lines are communicated. We work closely
together to evaluate and test the product for safety, micro, stability,
performance, claims substantiation and issue redirects as needed
throughout the process. There are many steps before a final formula is
approved, and we work very closely with the formulators and
manufacturing personnel all along the way. It can take 1-3 years from
concept to launch depending on the type of product.
Question 3d. What safeguards do companies employ to ensure that
products do not become contaminated with allergens from other products?
Answer 3d. This is best answered by an expert in manufacturing and/
or a raw material supplier. They can speak to the steps that are taken
in the manufacturing plants of both the fillers and raw material
suppliers to ensure there is no cross contamination of the raw
materials and the finished product.
Question 3e. How do companies test for allergenicity in their final
products?
Answer 3e. This is done using the HRIPT test (Human Repeat Insult
Patch Testing), and is performed by independent labs that specialize in
allergy and irritancy testing of cosmetics and personal care products.
Question 4. Together, PCPC and ICMAD represent almost all of the
cosmetic companies in the United States. Members of PCPC must agree to
a Consumer Commitment Code and ICMAD members must adhere to a Code of
Ethics, both of which state that the company will prioritize product
quality and safety. What tools do PCPC and ICMAD use to ensure that its
members uphold their commitment to consumers?
Answer 4. ICMAD and PCPC would the best resources to answers this
question.
senator enzi
Question 1a. The Personal Product Safety Act includes packers and
holders in its definition of a ``facility'' which has raised concerns
about the fee payment obligations.
Please provide specific examples of cosmetic products which have
become contaminated while in transit, under the authority of a packer
or a holder, or a contract manufacturer.
Answer 1a. I have no personal knowledge of any examples like this
happening in our industry as the products are very well sealed. Experts
in this area can be provided to answer this question.
Question 1b. What safeguards could be put in place to ensure that
packers, holders, and contract manufacturers, are not paying fees that
have already been paid by manufactures?
Answer 1b. This is out of my area of expertise, I will defer to
other experts that can answer this.
Question 2a. There was no discussion during the hearing about how
the Personal Care Product Safety Act would affect the cost of insurance
for the cosmetic industry. How do the insurance premiums of cosmetic
companies compare to other FDA regulated product categories?
Question 2b. What is the average premium for a cosmetic company
which has gross annual domestic sales of $100,000?
Question 2c. What is the average premium for a cosmetic company
which has gross annual domestic sales of $500,000?
Answer 2a, 2b, and 2c. I do not have access to this information but
we do have an insurance expert in this field at ICMAD that provides
insurance to a large number of small cosmetic companies.
Question 3a. The Personal Care Product Safety Act mandates
registration with the Food and Drug Administration (FDA) of all
facilities which engage in manufacturing or processing of a cosmetic
product or a cosmetic formulation distributed in the United States. The
act excludes in its definition of a ``facility'' those domestic
cosmetic manufacturers who had less than $100,000 in gross annual sales
of cosmetic products. Is the $100,000 gross annual sales threshold an
adequate standard for the definition of a ``facility?''
Question 3b. What specific industries have expressed concern over
the $100,000 threshold in the definition of ``facility?''
Question 3c. Have any specific industries advocated for a higher
annual sales threshold in the definition?
Answer 3a, 3b, and 3c. I will defer this question to the specific
experts in this field, as I don't have access to the information to be
able to answer these questions.
Question 4a. The Personal Care Product Safety Act states that
cosmetic ingredient statements shall be submitted to the FDA for each
cosmetic product. However, it allows for the FDA to permit a simplified
cosmetic ingredient statement for those businesses which average less
than $500,000 in annual domestic cosmetic sales over a 3-year period.
What is the average number of individuals employed by cosmetic
companies which average $500,000 in domestic sales over a 3-year
period?
Question 4b. Have any specific industries expressed concern over
the $500,000 threshold?
Question 4c. Have any specific industries publicly or privately
advocated for a higher threshold to qualify for a simplified ingredient
statement?
Answer 3a, 3b, and 3c. I will defer this question to the specific
experts in this field, as I don't have access to the information to be
able to answer these questions.
senator hatch
Question. FDA has a draft guidance on cosmetic good manufacturing
practices, which they initially published in 1997 and have revised
twice since then, once in April 2008 and again more recently in June
2013. If FDA were to finalize this guidance, or require manufacturers
to comply through rulemaking, how would it provide greater clarity for
the full range of manufacturers regarding best practices for
manufacturing safe cosmetic and personal care products? If the FDA is
updating its thinking in its regulatory capacity, I would think that
finalizing guidance provides more certainty for the industry than
having a lingering updated draft guidance.
Answer. I completely agree and support FDA finalizing its guidance
on good manufacturing practices for the cosmetics industry, both for
U.S.-based companies and those international manufacturers that import
products to the U.S. market. This is especially important for small
business owners that outsource production to third party contract
manufacturers, so we can be assured that all manufacturers are
complying with good manufacturing practices. It would provide needed
clarity for all parties, establish a level playing field for all
companies and increase consumer confidence.
senator baldwin
Question. Thank you for sharing your perspective as a small
business owner. As we work to modernize oversight of cosmetics and
strengthen consumer product safety, we must also ensure that Wisconsin
companies have the opportunity to succeed and should look for ways to
assist our small businesses with substantiating the safety of their
products. The bill that I introduced in the House of Representatives,
the Safe Cosmetics Act, would create a publicly accessible database of
safety studies and toxicological properties of ingredients generated by
scientific authoritative bodies, State and Federal Governments, and
manufacturers. How can improving data sharing of safety studies reduce
duplicative testing and help ease the burden on small businesses who
may not have the resources to complete these studies on their own?
Answer. Data sharing would be very helpful and I'm personally in
favor of eliminating requirements that would mean duplicative testing
and/or trigger animal testing of an ingredient that has already been
established by toxicologists as safe. This type of shared database
would serve to ease the cost burden on small business and allow us to
use existing safety data instead of starting from scratch and
duplicating very costly studies, including potentially being forced to
do animal testing to re-establish an ingredient's safety. There are
several excellent resources now, such as CIR and Coslink (EU database),
that are publicly available and contain comprehensive, peer reviewed
safety and toxicology data from experts worldwide. We need to be sure
that the databases set up under the new law would not only use
existing, peer reviewed data, but also not be too technical and dense
so that small business owners are not able to readily interpret the
final safety determination about each ingredient. Note: This is a
question that technical experts in the field of toxicology and
regulatory can more thoroughly address.
[Whereupon, at 11:13 a.m., the hearing was adjourned.]